Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-29 @ 4:10 AM
Study NCT ID:
NCT01521260
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implant Surface Decontamination in Peri-implantitis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'y.c.m.de.waal@umcg.nl', 'phone': '+31 50-3639051', 'title': 'Y.C.M. de Waal', 'organization': 'University Medical Center Groningen - Center for dentistry and oral hygiene'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chlorhexidine Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Bacterial Load on the Exposed Implant Surface', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'implants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.'}, {'id': 'OG001', 'title': 'Chlorhexidine Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.77', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'LOG_MEAN', 'timeFrame': 'During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.', 'description': 'Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure. The log-transformed mean change in bacterial load is calculated (difference between the two time points --\\> difference in sample BEFORE decontamination and AFTER decontamination procedure).', 'unitOfMeasure': 'log (colony forming units/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants'}, {'type': 'SECONDARY', 'title': 'Bleeding on Probing', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Probing Pocket Depth', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Suppuration on Probing', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Microbiological Composition of the Peri-implant Sulcus', 'timeFrame': 'baseline (T0), 3 and 12 months after intervention (T3, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Radiographic Marginal Bone Level on Standardized Intraoral Radiographs', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Presence of Plaque', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Presence of Calculus', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Marginal Soft Tissue Recession', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Implant Failure', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'description': 'defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Complications and Adverse Events', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.'}, {'id': 'FG001', 'title': 'Chlorhexidine Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment period: october 2009-september 2010 location: University Medical Center Groningen', 'preAssignmentDetails': "Assessed for eligibility:55 patients Excluded 25, because 'not meeting inclusion criteria (n=20) or 'declined to participate' (n=5)"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.'}, {'id': 'BG001', 'title': 'Chlorhexidine Group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2012-01-18', 'resultsFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-28', 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Bacterial Load on the Exposed Implant Surface', 'timeFrame': 'During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.', 'description': 'Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure. The log-transformed mean change in bacterial load is calculated (difference between the two time points --\\> difference in sample BEFORE decontamination and AFTER decontamination procedure).'}], 'secondaryOutcomes': [{'measure': 'Bleeding on Probing', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Probing Pocket Depth', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Suppuration on Probing', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Microbiological Composition of the Peri-implant Sulcus', 'timeFrame': 'baseline (T0), 3 and 12 months after intervention (T3, T12)'}, {'measure': 'Radiographic Marginal Bone Level on Standardized Intraoral Radiographs', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Presence of Plaque', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Presence of Calculus', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Marginal Soft Tissue Recession', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}, {'measure': 'Implant Failure', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)', 'description': 'defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection'}, {'measure': 'Complications and Adverse Events', 'timeFrame': 'baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental implants', 'microbiology', 'chlorhexidine'], 'conditions': ['Peri-implantitis', 'Periodontal Disease']}, 'descriptionModule': {'briefSummary': 'Peri-implantitis is an infectious disease that resides in the mucosa surrounding dental implants and also affects the supporting bone. Because the number of implants placed in everyday clinical practice is continuously increasing, it is reasonable to anticipate an increasing prevalence of peri-implantitis. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating peri-implantitis.\n\nThe primary objective of this controlled clinical study is to evaluate the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a chlorhexidine or placebo solution. The secondary objectives are to assess both the clinical and the microbiological effectiveness of treatment of peri-implantitis.\n\nIt is hypothesized that rinsing of the implant surface using a 0.12% chlorhexidine solution does not lead to better microbiological and clinical results compared to rinsing with a placebo solution.\n\nThe present study is a double-blind, placebo-controlled, randomized clinical trial.\n\nAdult patients with at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis will be included in this study.\n\nImplants with peri-implantitis lesions will be surgically exposed, followed by mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline followed by either 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine) (control group) or 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) (test group). After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. For both groups the surgery is followed by 2 weeks of mouthrinses with 0,12% chlorhexidine + Cetylpyridinium Chloride (CPC) without alcohol (Perio-aid®) two times daily during 30 seconds.\n\nThe main study parameter is the microbial composition of the biofilm on the dental implant surface. Secondary study parameters are bleeding on probing, probing pocket depth, suppuration on probing, microbiological composition of the peri-implant sulcus, radiographic marginal bone level on standardized intraoral radiographs, presence of plaque, presence of calculus, marginal soft tissue recession implant failure, complications and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is ≥ 18 years of age\n* The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;\n* The implants have been exposed to the oral environment for at least two years;\n* The patient is capable of understanding and giving informed consent.\n\nExclusion Criteria:\n\n* Medical and general contraindications for the surgical procedures;\n* A history of local radiotherapy to the head and neck region;\n* Pregnancy and lactation;\n* Diabetes;\n* Systemic use of antibiotics during the last 3 months;\n* Long-term use of anti-inflammatory drugs;\n* Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;\n* Active, uncontrolled periodontal pathology of the remaining dentition;\n* Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 3 months;\n* Use of mouthrinses;\n* Bruxism;\n* Implants placed in skin grafted areas;\n* Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);\n* Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;\n* Implant mobility;\n* Implants at which no position can be identified where proper probing measurements can be performed;\n* Previous surgical treatment of the peri-implantitis lesions;\n* Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).'}, 'identificationModule': {'nctId': 'NCT01521260', 'briefTitle': 'Implant Surface Decontamination in Peri-implantitis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Microbiological and Clinical Evaluation of Different Implant Surface Decontaminating Procedures in the Surgical Treatment of Peri-implantitis; a Double Blind Placebo Controlled Randomized Clinical Study', 'orgStudyIdInfo': {'id': '27147.042.09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.', 'interventionNames': ['Procedure: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine group', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.', 'interventionNames': ['Procedure: Chlorhexidine']}], 'interventions': [{'name': 'placebo', 'type': 'PROCEDURE', 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.', 'armGroupLabels': ['Placebo group']}, {'name': 'Chlorhexidine', 'type': 'PROCEDURE', 'otherNames': ['Perio-aid'], 'description': 'Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.', 'armGroupLabels': ['Chlorhexidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Yvonne CM de Waal, dds', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Arie Jan van Winkelhoff, prof. dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}