Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT05275894
Status:
UNKNOWN
Last Update Posted:
2023-11-24
First Post:
2022-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-surgical Electrolytic Cleaning 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008866', 'term': 'Microsurgery'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008846', 'term': 'Micromanipulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-implant disease resolution at 6 month', 'timeFrame': '6 months', 'description': 'Probing depth \\< 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz \\& Chapple 2012)'}, {'measure': 'Peri-implant disease resolution at 12 month', 'timeFrame': '12 months', 'description': 'Probing depth \\< 5 mm, with absence of bleeding or suppuration and no additional'}], 'secondaryOutcomes': [{'measure': 'Implant survival rate at 6 months', 'timeFrame': '6 months', 'description': 'Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.'}, {'measure': 'Implant survival rate at 12 months', 'timeFrame': '12 months', 'description': 'Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.'}, {'measure': 'Implant plaque index at 6 months', 'timeFrame': '6 months', 'description': 'Implant plaque index (PI) (at 6 sites/implant)(+/-).'}, {'measure': 'Implant plaque index at 12 months', 'timeFrame': '12 months', 'description': 'Implant plaque index (PI) (at 6 sites/implant)(+/-).'}, {'measure': 'Peri-implant probing depth at 6 months', 'timeFrame': '6 months', 'description': 'Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).'}, {'measure': 'Peri-implant probing depth at 12 months', 'timeFrame': '12 months', 'description': 'Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).'}, {'measure': 'Bleeding on probing at 6 months', 'timeFrame': '6 months', 'description': 'Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).'}, {'measure': 'Bleeding on probing at 12 months', 'timeFrame': '12 months', 'description': 'Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).'}, {'measure': 'Suppuration at 6 months', 'timeFrame': '6 months', 'description': 'Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) nice, regular, unpleasant, very unpleasant).'}, {'measure': 'Suppuration at 12 months', 'timeFrame': '12 months', 'description': 'Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)'}, {'measure': 'Recession of the mucosal margin at 6 months', 'timeFrame': '6 months', 'description': 'Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).'}, {'measure': 'Recession of the mucosal margin at 12 months', 'timeFrame': '12 months', 'description': 'Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).'}, {'measure': 'Bone loss at 6 months', 'timeFrame': '6 months', 'description': 'Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures.\n\nDigital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length.'}, {'measure': 'Bone loss at 12 months', 'timeFrame': '12 months', 'description': 'Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures.\n\nDigital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length.'}, {'measure': 'Patient centred outcomes of the electrolytic cleaning after 6 months', 'timeFrame': '6 months', 'description': 'Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).'}, {'measure': 'Patient centred outcomes of the electrolytic cleaning after 12 months', 'timeFrame': '12 months', 'description': 'Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).'}, {'measure': 'Overall satisfaction after 6 months', 'timeFrame': '6 months', 'description': 'Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).'}, {'measure': 'Overall satisfaction after 12 months', 'timeFrame': '12 months', 'description': 'Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-implantitis', 'Electrolytic cleaning', 'Implant decontamination', 'Non-surgical treatment'], 'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.\n\nA prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.', 'detailedDescription': 'Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.\n\nTherapeutic success is defined as as a composite index (Sanz \\& Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth \\< 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration.\n\nThis study will be carried out in the following centers:\n\n* Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain)\n* CEOSA-Madrid Private Dental Centre\n\nAfter the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at:\n\n* 3 months.\n* 6 months.\n* 12 months. After non-surgical therapy, patients will be included in a strict peri-implant maintenance therapy program to avoid re-contamination of the affected implants. Removal of biofilm with air polishing without anaesthesia and oral hygiene instruction reinforcement will be performed at: 3 months, 6 months, 9 months and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age \\> 18 years.\n* Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018)\n* Peri-implant bone loss \\< 2/3\n* History of treated periodontal diseases (Caton 2018).\n* Screw retained prosthesis that can be easily unscrewed.\n* Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly.\n* Absence of implant mobility\n\nExclusion Criteria:\n\nSystemic exclusion criteria\n\n* Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL\n* Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation)\n* Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism.\n* History of leukocyte dysfunction and deficiencies.\n* History of neoplastic disease requiring the use of radiation or chemotherapy.\n* Patients with chronic renal failure requiring dialysis.\n* Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications.\n* History of uncontrolled endocrine disorders: hypothyroidism or diabetes.\n* Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning.\n* Alcoholism or drug abuse.\n* History of immunodeficiency syndromes.\n* Tobacco consumption (smoking more than 10 cigarettes per day)\n* Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment\n\nLocal exclusion criteria\n\n* Mucosal diseases such as erosive lichen planus in the area to be treated.\n* History of local irradiation therapy.\n* Implants with peri-implant bone loss beyond 2/3 of the implant length'}, 'identificationModule': {'nctId': 'NCT05275894', 'briefTitle': 'Non-surgical Electrolytic Cleaning Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study', 'orgStudyIdInfo': {'id': 'UCM ACA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-surgical electrolytic cleaning', 'description': "* Implant hygiene instructions and removal of the prosthesis\n* Local anaesthesia\n* Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)\n* Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).\n* Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).\n* Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.\n* Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).\n* If necessary, modification and polishing of the prosthesis to make it cleanable.", 'interventionNames': ['Behavioral: Implant hygiene instructions and removal of the prosthesis', 'Procedure: Non-surgical peri-implantitis treatment /microsurgery', 'Procedure: Implant surface decontamination 1(ultrasonic device)', 'Procedure: Implant surface decontamination 2 (air polishing)', 'Procedure: Implant surface decontamination 3 (electrolytic cleaning)', 'Drug: Antibiotic treatment (Metronidazole)', 'Procedure: Modification and polishing of the prosthesis']}], 'interventions': [{'name': 'Implant hygiene instructions and removal of the prosthesis', 'type': 'BEHAVIORAL', 'description': 'Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis', 'armGroupLabels': ['Non-surgical electrolytic cleaning']}, {'name': 'Non-surgical peri-implantitis treatment /microsurgery', 'type': 'PROCEDURE', 'description': 'Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) after applying local anestesia', 'armGroupLabels': ['Non-surgical electrolytic cleaning']}, {'name': 'Implant surface decontamination 1(ultrasonic device)', 'type': 'PROCEDURE', 'description': 'Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).', 'armGroupLabels': ['Non-surgical electrolytic cleaning']}, {'name': 'Implant surface decontamination 2 (air polishing)', 'type': 'PROCEDURE', 'description': 'Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).', 'armGroupLabels': ['Non-surgical electrolytic cleaning']}, {'name': 'Implant surface decontamination 3 (electrolytic cleaning)', 'type': 'PROCEDURE', 'description': "Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.", 'armGroupLabels': ['Non-surgical electrolytic cleaning']}, {'name': 'Antibiotic treatment (Metronidazole)', 'type': 'DRUG', 'otherNames': ['Metronidazole'], 'description': 'Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).', 'armGroupLabels': ['Non-surgical electrolytic cleaning']}, {'name': 'Modification and polishing of the prosthesis', 'type': 'PROCEDURE', 'description': 'If necessary, modification and polishing of the prosthesis to make it cleanable.', 'armGroupLabels': ['Non-surgical electrolytic cleaning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Ana Carrillo de Albornoz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Mariano Sanz Alonso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Complutense Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}