Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-28 @ 9:34 PM
Study NCT ID:
NCT03163602
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2017-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Peri-implantitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D003646', 'term': 'Debridement'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-05-20', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Success Outcome', 'timeFrame': '12 months', 'description': 'Number of participants with treated implant with successful outcome: no bleeding or suppuration on probing, no further bone loss, PD ≤ 5 mm'}], 'secondaryOutcomes': [{'measure': 'probing depth change', 'timeFrame': '12 months', 'description': 'mm'}, {'measure': 'radiographic bone level change', 'timeFrame': '12 months', 'description': 'mm'}, {'measure': 'change in peri-implant soft tissue level', 'timeFrame': '12 months', 'description': 'mm'}, {'measure': 'patient reported outcomes', 'timeFrame': '1, 6, 12 months', 'description': 'VAS scores'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-Implantitis', 'Infection', 'Bone substitutes'], 'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '22834392', 'type': 'BACKGROUND', 'citation': 'Esposito M, Grusovin MG, Worthington HV. Treatment of peri-implantitis: what interventions are effective? A Cochrane systematic review. Eur J Oral Implantol. 2012;5 Suppl:S21-41.'}, {'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': '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': '27335316', 'type': 'BACKGROUND', 'citation': 'Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.'}, {'pmid': '37382408', 'type': 'DERIVED', 'citation': 'Heitz-Mayfield LJA, Heitz F, Koong B, Huang T, Chivers P. Surgical peri-implantitis treatment with and without guided bone regeneration. A randomized controlled trial. Clin Oral Implants Res. 2023 Sep;34(9):892-910. doi: 10.1111/clr.14116. Epub 2023 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. Outcome measures will include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.', 'detailedDescription': 'The aim of this randomized controlled study is to evaluate the possible benefit of a regenerative treatment protocol (placing a bone substitute covered by a bioresorbable collagen membrane) compared to surgical treatment alone, for peri-implantitis therapy.\n\nThe hypothesis is that there will be a greater number of patients with successful treatment of peri-implantitis following the use of a bone substitute/collagen membrane compared to surgical peri-implantitis therapy without the bone substitute/collagen membrane.\n\nThe project will be conducted as a two-armed randomized controlled clinical trial of 1-year duration. Forty systemically healthy patients with ≥1 implant diagnosed with peri-implantitis requiring surgical therapy will be enrolled.\n\nBaseline measurements will be performed after non-surgical therapy (removal supramucosal biofilm/calculus, oral hygiene instruction and correction of prosthetic factors) and treatment of periodontitis.\n\nBaseline measurements will include probing depth, position of mucosal margin, presence of plaque, presence of bleeding and/or suppuration on probing, PROMs and radiographs. Measurements will be recorded at 4 sites per implant.\n\nFollowing the baseline measurements participants will be randomly assigned to either Control Group (Group 1): access flap and implant cleaning or Test Group (Group 2): access flap, implant cleaning and addition of a bone substitute material covered by a collagen membrane.\n\nParticipants in both treatment groups will be prescribed systemic antimicrobials (Amoxicillin 500 mg tds and Metronidazole 400 mg tds) for 7 days starting from the day of surgery.\n\nIn addition an antibacterial mouthrinse (chlorhexidine digluconate 0.2%) will be prescribed for a period of 4 weeks following surgery.\n\nParticipants will be asked to attend follow-up visits for review of healing (week 1 and 4) and maintenance care (3, 6, 9, and 12 months).\n\nClinical examinations will be performed by a calibrated blinded examiner at baseline and 12 months after therapy. Clinical measurements will be taken using a periodontal probe at 4 sites per implant to record presence of plaque, bleeding, probing depth and recession of the soft tissue.\n\nPROMS will be assessed at 1 week, 4 weeks and at 12 months. Radiographic assessments Intra-oral radiographs and cone beam CT scan will be obtained prior to surgery and at 12 months. Oral-maxillofacial radiologists will. perform the radiographic analysis and will be blinded to the treatment procedure.\n\nPrimary outcome variables include (1) resolution of peri-implantitis (probing depth reduction and absence of BoP, suppuration) (2) recurrence of disease (BoP, suppuration and increase in PPD and progression of bone loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPresence of ≥ 1 implant with a probing depth (PD) ≥ 5 mm with bleeding and/or suppuration (SUP) on probing, and peri-implant bone loss ≥ 3mm with an intraosseous defect component\n\nExclusion Criteria:\n\n* Smokers \\> 10 cigarettes per day\n* Patients with uncontrolled diabetes mellitus\n* Pregnant or lactating women (self reported)\n* Patients with a systemic illness that preclude them from oral surgery\n* Patients with an allergy to amoxicillin or metronidazole or chlorhexidine.\n* Patients requiring antibiotic prophylaxis and Patients who have taken antibiotics in the past 3 months'}, 'identificationModule': {'nctId': 'NCT03163602', 'acronym': 'STP', 'briefTitle': 'Surgical Treatment of Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'The University of Western Australia'}, 'officialTitle': 'Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': '15-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group 1', 'description': 'Access flap, implant surface decontamination (saline), systemic antibiotics (amoxicillin 500 mg and metronidazole 400 g, 3 x day for 7 days)', 'interventionNames': ['Drug: Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Group 2', 'description': 'Access flap, implant surface debridement, systemic antibiotics (amoxicillin 500 mg, metronidazole 400 g, 3 x day for 7 days), bovine bone substitute material (BioOss®) and collagen membrane (BioGide®)', 'interventionNames': ['Device: Test group']}], 'interventions': [{'name': 'Control group', 'type': 'DRUG', 'otherNames': ['Access flap and debridement'], 'description': 'Access flap and debridement', 'armGroupLabels': ['Control Group 1']}, {'name': 'Test group', 'type': 'DEVICE', 'otherNames': ['BioOss®, BioGide® collagen membrane'], 'description': 'Regenerative treatment', 'armGroupLabels': ['Test Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'The University of Western Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Lisa Heitz-Mayfield, OdontDr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Western Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osteology Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adj Professor', 'investigatorFullName': 'Lisa Heitz-Mayfield', 'investigatorAffiliation': 'The University of Western Australia'}}}}