Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-31 @ 11:56 PM
Study NCT ID:
NCT05899933
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2023-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The experimental protocol is designed as a double-blind, randomized clinical trial with a 12-month duration and a parallel design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success as described by the composite outcome of probing pocket depth (PPD) ≤5 mm, absence of bleeding on probing (BoP) and/or suppuration and bone loss ≤0.5 mm between week 2 and 12 months post-surgery, at 12-month examination post-surgery', 'timeFrame': '12 months post-surgery', 'description': 'The percentage of treatment success will be calculated from the total amount of treated implants.\n\n* PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants.\n* BoP will be assessed dichotomously (1=presence, 0=absence) within 30 seconds after probing at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants.\n* Mean change in mm in mean marginal bone level (mesial and distal) will be assessed using an image-processing software.\n\nStandardized intra-oral radiographs will be obtained at each time point using a reproducible technique.\n\nMarginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact.'}, {'measure': 'Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean total CFU counts from Baseline to Week 6 after non-surgical therapy will be assessed at each experimental group.\n\nMean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR).\n\nSubgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline and at Week 6 after completion of non-surgical therapy.\n\nDetection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.'}, {'measure': 'Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean total CFU counts from Baseline to 12 months after surgical therapy will be assessed at each experimental group.\n\nMean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR).\n\nSubgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline, 3 months post-surgery, 6 months post-surgery and 12 months post-surgery.\n\nDetection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.'}, {'measure': 'Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants of the control group from Baseline to 12 months follow-up visit', 'timeFrame': 'Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit', 'description': 'Mean total CFU counts from Baseline to 12 months after Baseline examination will be assessed.\n\nMean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR).\n\nSubgingival samples will be obtained with three sterile paper points from the implant site with the easiest access for sampling at Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit.\n\nDetection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.'}], 'secondaryOutcomes': [{'measure': 'Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean peri-implant probing pocket depth (PPD) will be assessed at Baseline examination and Week 6 after non-surgical therapy.\n\nAt each examination, PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean peri-implant probing pocket depth (PPD) will be assessed at Baseline examination and 12 months after surgical therapy.\n\nAt each examination, PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean change from Baseline in peri-implant probing pocket depth at Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean change in mm in peri-implant probing pocket depth (PPD) will be assessed between Baseline examination and Week 6 after non-surgical therapy.\n\nAt each examination, PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean change in mm in peri-implant probing pocket depth (PPD) will be assessed between Baseline and 12 months after completion of surgical therapy.\n\nPPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Percentage of sites with bleeding on probing from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Bleeding on probing will be assessed dichotomously as present (1 for bleeding presence) or absent (0 for bleeding absence) within 30 seconds after probing.\n\nBoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)'}, {'measure': 'Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Bleeding on probing will be assessed dichotomously as present (1 for bleeding presence) or absent (0 for bleeding absence) within 30 seconds after probing.\n\nBoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)'}, {'measure': 'Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Change in percentage of sites with bleeding index score (BI) from 0 to 3 will be recorded between Baseline and Week 6 after completion of non-surgical therapy.\n\nBI will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) within 30 seconds after probing.\n\nBleeding will be graded as: 0= no bleeding, 1= dot of bleeding, 2= line of bleeding, 3= profuse bleeding.'}, {'measure': 'Change from Baseline in bleeding index score to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Change in percentage of sites with bleeding index score (BI) from 0 to 3 will be recorded between Baseline and 12 months after completion of surgical therapy.\n\nBI will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) within 30 seconds after probing.\n\nBleeding will be graded as: 0= no bleeding, 1= dot of bleeding, 2= line of bleeding, 3= profuse bleeding'}, {'measure': 'Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Suppuration on probing (SoP) will be assessed dichotomously as present (1 for suppuration presence) or absent (0 for suppuration absence) within 30 seconds after probing.\n\nSoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)'}, {'measure': 'Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Suppuration on probing (SoP) will be assessed dichotomously as present (1 for suppuration presence) or absent (0 for suppuration absence) within 30 seconds after probing.\n\nSoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)'}, {'measure': 'Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs', 'timeFrame': 'Week 2 post-surgery, 12 months post-surgery', 'description': 'Mean change in mm between week 2 and 12 months post-surgery in mean marginal bone level (mesial and distal) will be assessed using an image-processing software.\n\nStandardized intra-oral radiographs will be obtained at Week 2 post-surgery and at 12 months post-surgery examination, using a reproducible technique with an occlusal bite index with acrylic resin mounted on a film holder.\n\nMarginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact, measured at the mesial and distal aspects of the studied implants at each time-point.'}, {'measure': 'Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed at Baseline examination and Week 6 after non-surgical therapy.\n\nCAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean peri-implant clinical attachment level from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed at Baseline examination and Week 6 after non-surgical therapy.\n\nCAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean change from Baseline in peri-implant clinical attachment level to Week 6 after surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed from Baseline examination to Week 6 after completion of surgical therapy.\n\nCAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean change from Baseline in peri-implant clinical attachment level to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed from Baseline examination to 12 months after completion of surgical therapy.\n\nCAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean peri-implant recession from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean peri-implant recession (REC) in mm will be assessed at Baseline examination and Week 6 after non-surgical therapy.\n\nREC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean peri-implant recession from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean peri-implant recession (REC) will be assessed in mm from Baseline examination to 12 months after surgical therapy.\n\nREC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean change from Baseline in peri-implant recession at Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean change in mm in peri-implant recession (REC) will be assessed between Baseline examination and Week 6 after non-surgical therapy.\n\nREC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean change from Baseline in peri-implant recession to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean change in mm in peri-implant recession (REC) will be assessed from Baseline examination to 12 months after completion of surgical therapy.\n\nREC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.'}, {'measure': 'Mean local plaque score from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Mean number of sites with plaque presence at targeted implants will be assessed between Baseline examination and Week 6 after non-surgical therapy.\n\nLocal plaque score (LPS) will be calculated by assigning a binary score at each implant surface (1 for plaque presence, 0 for plaque absence) Presence or absence of plaque will be recorded at four sites per targeted implant (mesial, buccal, distal, lingual)'}, {'measure': 'Mean local plaque score from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Mean number of sites with plaque presence at targeted implants will be assessed from Baseline to 12 months after completion of surgical therapy.\n\nLocal plaque score (LPS) will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence.\n\nPresence or absence of plaque will be recorded at 4sites per tooth/ implant (mesial, buccal, distal, lingual)'}, {'measure': 'Full mouth plaque score from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Percentage of full mouth plaque score (FMPS) presence from Baseline to Week 6 after completion of non-surgical therapy.\n\nFMPS will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence.\n\nPresence or absence of plaque will be recorded at four sites per tooth/ implant (mesial, buccal, distal, lingual)'}, {'measure': 'Full mouth plaque score from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Percentage of full mouth plaque score (FMPS) presence from Baseline to 12 months after completion of surgical therapy.\n\nFMPS will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence.\n\nPresence or absence of plaque will be recorded at 4sites per tooth/ implant (mesial, buccal, distal, lingual)'}, {'measure': 'Full mouth bleeding score from Baseline to Week 6 after non-surgical therapy', 'timeFrame': 'Baseline, Week 6 after non-surgical therapy', 'description': 'Percentage of full mouth bleeding score (FMBS) presence from Baseline to Week 6 after completion of non-surgical therapy.\n\nFMBS will be calculated by assigning a binary score at each surface ( 1 for bleeding presence, 0 for bleeding absence) within 30 seconds after probing and calculating the percentage of total tooth/ implant surfaces that bled upon probing.\n\nPresence or absence of bleeding will be recorded at six sites per tooth/ implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)'}, {'measure': 'Full mouth bleeding score from Baseline to 12 months after surgical therapy', 'timeFrame': 'Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery', 'description': 'Percentage of full mouth bleeding score (FMBS) presence from Baseline to 12 months after completion of surgical therapy.\n\nFMBS will be calculated by assigning a binary score at each surface ( 1 for bleeding presence, 0 for bleeding absence) within 30 seconds after probing and calculating the percentage of total tooth/ implant surfaces that bled upon probing.\n\nPresence or absence of bleeding will be recorded at 6 sites per tooth/ implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)'}, {'measure': "Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at Week 2 post-surgery", 'timeFrame': 'Week 2 post-surgery', 'description': 'Participants will complete a questionnaire at Week 2 post-surgery in order to assess the intensity of post-surgical pain using a visual analogue scale (VAS, 10cm). The following question will be asked:\n\n-From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").'}, {'measure': "Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at 12 months post-surgery", 'timeFrame': '12 months post-surgery', 'description': 'Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of pain at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:\n\nFrom 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").'}, {'measure': "Evaluation of participants' pain during toothbrushing on the visual analogue scale (VAS, 10cm) at 12 months post-surgery", 'timeFrame': '12 months post-surgery', 'description': 'Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of pain during toothbrushing at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:\n\nFrom 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").'}, {'measure': "Evaluation of participants' swelling on the visual analogue scale (VAS) at Week 2 post-surgery", 'timeFrame': 'Week 2 post-surgery', 'description': 'Participants will complete a questionnaire at Week 2 post-surgery in order to assess the intensity of post-surgical swelling using a visual analogue scale (VAS, 10cm). The following question will be asked:\n\n-From 0-10 rate the amount of post-surgery swelling in the treated areas. (0 represents "no swelling" and 10 "maximum swelling").'}, {'measure': "Evaluation of participants' bleeding tendency when applying oral hygiene on the visual analogue scale (VAS, 10cm) at 12 months post-surgery", 'timeFrame': '12 months post-surgery', 'description': 'Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of bleeding during toothbrushing or interdental cleaning at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:\n\nassess the presence and intensity of pain during toothbrushing at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:\n\n-From 0-10 rate the amount of bleeding when applying oral hygiene to the areas you treated. (0 represents "no bleeding" and 10 "maximum bleeding").'}, {'measure': 'Number of days of analgesic consumption at Week 2 post-surgery', 'timeFrame': 'Week 2 post-surgery', 'description': 'Participants will complete a questionnaire at Week 2 post-surgery in order to record the number of days analgesics were needed .'}, {'measure': "Evaluation of patients' satisfaction on the visual analogue scale (VAS) at Week 2 post-surgery", 'timeFrame': 'Week 2 post-surgery', 'description': 'Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:\n\n-If necessary, would you do this treatment again? (0 represents aversion to repeating the treatment and 10 that you would repeat it comfortably).'}, {'measure': "Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at Week 2 post-surgery", 'timeFrame': 'Week 2 post-surgery', 'description': 'Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:\n\n-Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).'}, {'measure': "Evaluation of patients' satisfaction on the visual analogue scale (VAS) at 12 months post-surgery", 'timeFrame': '12 months post-surgery', 'description': 'Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:\n\n-Are you satisfied with the treatment you received? (0 represents "not at all satisfied" and 10 "completely satisfied").'}, {'measure': "Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at 12 months post-surgery", 'timeFrame': '12 months post-surgery', 'description': 'Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:\n\n-Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-Implantitis', 'Surgical therapy', 'Implantoplasty', 'Air-abrasive device', 'Erythritol powder', 'Peri-Implant microbiota'], 'conditions': ['Peri-Implantitis', 'Peri-Implant Health']}, 'referencesModule': {'references': [{'pmid': '26285807', 'type': 'BACKGROUND', 'citation': 'Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.'}, {'pmid': '21613949', 'type': 'BACKGROUND', 'citation': 'Casado PL, Otazu IB, Balduino A, de Mello W, Barboza EP, Duarte ME. Identification of periodontal pathogens in healthy periimplant sites. Implant Dent. 2011 Jun;20(3):226-35. doi: 10.1097/ID.0b013e3182199348.'}, {'pmid': '25654499', 'type': 'BACKGROUND', 'citation': 'Charalampakis G, Belibasakis GN. Microbiome of peri-implant infections: lessons from conventional, molecular and metagenomic analyses. Virulence. 2015;6(3):183-7. doi: 10.4161/21505594.2014.980661. Epub 2015 Feb 5.'}, {'pmid': '21770994', 'type': 'BACKGROUND', 'citation': 'Charalampakis G, Rabe P, Leonhardt A, Dahlen G. A follow-up study of peri-implantitis cases after treatment. J Clin Periodontol. 2011 Sep;38(9):864-71. doi: 10.1111/j.1600-051X.2011.01759.x. Epub 2011 Jul 19.'}, {'pmid': '24158341', 'type': 'BACKGROUND', 'citation': 'Dabdoub SM, Tsigarida AA, Kumar PS. Patient-specific analysis of periodontal and peri-implant microbiomes. J Dent Res. 2013 Dec;92(12 Suppl):168S-75S. doi: 10.1177/0022034513504950. Epub 2013 Oct 24.'}, {'pmid': '24660207', 'type': 'BACKGROUND', 'citation': 'Heitz-Mayfield LJ, Mombelli A. The therapy of peri-implantitis: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:325-45. doi: 10.11607/jomi.2014suppl.g5.3.'}, {'pmid': '31923303', 'type': 'BACKGROUND', 'citation': 'Lasserre JF, Brecx MC, Toma S. Implantoplasty Versus Glycine Air Abrasion for the Surgical Treatment of Peri-implantitis: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2020 Jan/Feb;35(35):197-206. doi: 10.11607/jomi.6677.'}, {'pmid': '19126114', 'type': 'BACKGROUND', 'citation': 'Maximo MB, de Mendonca AC, Renata Santos V, Figueiredo LC, Feres M, Duarte PM. Short-term clinical and microbiological evaluations of peri-implant diseases before and after mechanical anti-infective therapies. Clin Oral Implants Res. 2009 Jan;20(1):99-108. doi: 10.1111/j.1600-0501.2008.01618.x.'}, {'pmid': '21323716', 'type': 'BACKGROUND', 'citation': 'Mombelli A, Decaillet F. 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A systematic review and Bayesian network meta-analysis of randomized clinical trials on non-surgical treatments for peri-implantitis. J Clin Periodontol. 2014 Oct;41(10):1015-25. doi: 10.1111/jcpe.12292. Epub 2014 Aug 11.'}, {'pmid': '34713471', 'type': 'BACKGROUND', 'citation': 'Blanco C, Pico A, Dopico J, Gandara P, Blanco J, Linares A. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial. J Clin Periodontol. 2022 Jan;49(1):15-27. doi: 10.1111/jcpe.13564. Epub 2021 Oct 28.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the present study is to compare the 1-year clinical, radiographic and microbiological outcomes and patients' satisfaction following surgical treatment of peri-implantitis after applying two different surface modification methods. Secondarily, analysis and comparison of the microbiological results of implants diagnosed and treated for peri-implantitis with healthy implants will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n* Participants ≥ 18 years and ≤ 80 years of age\n* Non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago\n* Implants in function for more than 1 year after suprastructure connection\n\nInclusion Criteria for implants diagnosed with Peri-Implantitis:\n\n* Presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling\n* Absence of implant mobility\n\n * in participants with more than one implant, the implant with the worst clinical condition will be studied.\n\nInclusion Criteria for implants diagnosed with Peri-Implant Health:\n\n* Absence of peri-implant signs of inflammation (redness, swelling)\n* Lack of bleeding on probing\n* Absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm\n\nExclusion Criteria:\n\n* Smokers\n* Uncontrolled diabetes mellitus (HBA1c \\>7)\n* Treatment with bisphosphonates\n* Needing antibiotic prophylaxis\n* Currently pregnant or breast-feeding women\n* History of systemic administration of antibiotic treatment during the preceding 3 months\n* Systemic conditions that contraindicate treatment\n* Use of medications known to induce gingival hyperplasia"}, 'identificationModule': {'nctId': 'NCT05899933', 'briefTitle': 'Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Implantoplasty Versus Implant Decontamination With Erythritol Air-abrasive Device During Surgical Therapy of Peri-implantitis. Clinical, Radiographic and Microbiological Evaluation. A Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'PERIO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantoplasty group', 'description': '6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implantoplasty will be applied as an implant surface modification method.', 'interventionNames': ['Procedure: Non-surgical peri-implant therapy', 'Procedure: Implantoplasty', 'Procedure: Prophylaxis']}, {'type': 'EXPERIMENTAL', 'label': 'Erythritol Air-abrasive device group', 'description': '6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.', 'interventionNames': ['Procedure: Non-surgical peri-implant therapy', 'Procedure: Erythritol Air-abrasive device', 'Procedure: Prophylaxis']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Participants with healthy implants will be the comparator group for the microbiological analysis.', 'interventionNames': ['Procedure: Prophylaxis']}], 'interventions': [{'name': 'Non-surgical peri-implant therapy', 'type': 'PROCEDURE', 'description': '2 weeks after baseline examination, non surgical therapy will be applied in implants diagnosed with peri-implantitis prior to enrollment in surgical therapy.\n\nFirstly, participants will be instructed in oral hygiene. Professional supragingival and subgingival debridement of implants/ teeth, including the selected for the study implants, will be performed. Local anesthesia will be performed, when needed. Targeted implants will be treated with PEEK-coating ultrasonic tips (Instrument PI; EMS), titanium curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), rubber cup and polishing paste. Possible adjustments to implant-borne prostheses will be considered, whenever possible. Re-evaluation of non-surgical therapy will be performed after 6 weeks.\n\nAt the 6-week reevaluation, participants with peri-implant probing pocket depth ≥5 mm and bleeding on probing and/or suppuration in patients with full mouth plaque score ≤20% will proceed to surgical therapy.', 'armGroupLabels': ['Erythritol Air-abrasive device group', 'Implantoplasty group']}, {'name': 'Implantoplasty', 'type': 'PROCEDURE', 'description': 'Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed.\n\nFollowing local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy) and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implantoplasty will be applied using tungsten carbide burs of various shapes and sizes (Peri-implantitis Kit; Meisinger) followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery.', 'armGroupLabels': ['Implantoplasty group']}, {'name': 'Erythritol Air-abrasive device', 'type': 'PROCEDURE', 'description': 'Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed.\n\nFollowing local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implant surface decontamination with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS) will be applied followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery.', 'armGroupLabels': ['Erythritol Air-abrasive device group']}, {'name': 'Prophylaxis', 'type': 'PROCEDURE', 'description': 'Supramucosal biofilm removal of implants/ teeth will be performed at, 3, 6, 9 and 12 months after surgical therapy for the Implantoplasty group and the Erythritol Air-abrasive device group and at 2 weeks, 3, 6, 9 and 12 months after baseline examination for the control group. Targeted implants will be treated with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS). During these appointments, patients will be re-motivated and re-instructed to oral-hygiene measures.', 'armGroupLabels': ['Control group', 'Erythritol Air-abrasive device group', 'Implantoplasty group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Yiorgos A. Bobetsis', 'role': 'CONTACT', 'email': 'ybobetsi@dent.uoa.gr', 'phone': '210-746-1097', 'phoneExt': '+30'}, {'name': 'Sotiria Tsantila', 'role': 'CONTACT', 'email': 'soteriatsantila@gmail.com', 'phone': '6975661234', 'phoneExt': '+30'}], 'facility': 'Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Yiorgos A. Bobetsis, Assistant Professor', 'role': 'CONTACT', 'email': 'ybobetsi@dent.uoa.gr', 'phone': '(+30) 210-746-1097'}, {'name': 'Sotiria Tsantila', 'role': 'CONTACT', 'email': 'soteriatsantila@gmail.com'}], 'overallOfficials': [{'name': 'Phoebus N. Madianos', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data requests will be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered.', 'ipdSharing': 'YES', 'description': 'The data that supports the findings of this study will be available from the corresponding author upon reasonable request.', 'accessCriteria': 'Access to trial individual participant data (IPD) can be requested by qualified investigators whose proposed research has received Institutional Review Board (IRB) approval. Data will be available via a data repository following execution of data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yiorgos A. Bobetsis', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}