Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-29 @ 3:24 PM
Study NCT ID:
NCT01857804
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2013-05-16
Is NOT 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'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pocket closure', 'timeFrame': '6 months, 1 year', 'description': 'absence of probing pocket depth \\> 5 mm and no bleeding on probing'}, {'measure': 'bone level stability', 'timeFrame': '1 year', 'description': 'no further peri-implant marginal bone loss in the observation period.'}], 'secondaryOutcomes': [{'measure': 'Quantitative and qualitative change in levels of the peri-implant microflora', 'timeFrame': '3 months, 6 months, 1 year', 'description': 'Quantitative and qualitative change in levels of the peri-implant microflora'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peri-implantitis', 'surgical therapy', 'systemic antibiotics', 'local antiseptics'], 'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '21092053', 'type': 'BACKGROUND', 'citation': 'Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.'}, {'pmid': '9151598', 'type': 'BACKGROUND', 'citation': 'Ericsson I, Persson LG, Berglundh T, Edlund T, Lindhe J. The effect of antimicrobial therapy on periimplantitis lesions. An experimental study in the dog. Clin Oral Implants Res. 1996 Dec;7(4):320-8. doi: 10.1034/j.1600-0501.1996.070404.x.'}, {'pmid': '12702106', 'type': 'BACKGROUND', 'citation': 'Gualini F, Berglundh T. Immunohistochemical characteristics of inflammatory lesions at implants. J Clin Periodontol. 2003 Jan;30(1):14-8. doi: 10.1034/j.1600-051x.2003.300103.x.'}, {'pmid': '14653386', 'type': 'BACKGROUND', 'citation': 'Leonhardt A, Dahlen G, Renvert S. Five-year clinical, microbiological, and radiological outcome following treatment of peri-implantitis in man. J Periodontol. 2003 Oct;74(10):1415-22. doi: 10.1902/jop.2003.74.10.1415.'}, {'pmid': '11488856', 'type': 'BACKGROUND', 'citation': 'Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.'}, {'pmid': '1298430', 'type': 'BACKGROUND', 'citation': 'Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.'}, {'pmid': '9151604', 'type': 'BACKGROUND', 'citation': 'Persson LG, Ericsson I, Berglundh T, Lindhe J. Guided bone regeneration in the treatment of periimplantitis. Clin Oral Implants Res. 1996 Dec;7(4):366-72. doi: 10.1034/j.1600-0501.1996.070410.x.'}, {'pmid': '11284540', 'type': 'BACKGROUND', 'citation': 'Persson LG, Ericsson I, Berglundh T, Lindhe J. Osseintegration following treatment of peri-implantitis and replacement of implant components. An experimental study in the dog. J Clin Periodontol. 2001 Mar;28(3):258-63. doi: 10.1034/j.1600-051x.2001.028003258.x.'}, {'pmid': '15841583', 'type': 'BACKGROUND', 'citation': 'Persson LG, Mouhyi J, Berglundh T, Sennerby L, Lindhe J. Carbon dioxide laser and hydrogen peroxide conditioning in the treatment of periimplantitis: an experimental study in the dog. Clin Implant Dent Relat Res. 2004;6(4):230-8. doi: 10.1111/j.1708-8208.2004.tb00039.x.'}, {'pmid': '10219130', 'type': 'BACKGROUND', 'citation': 'Wetzel AC, Vlassis J, Caffesse RG, Hammerle CH, Lang NP. Attempts to obtain re-osseointegration following experimental peri-implantitis in dogs. Clin Oral Implants Res. 1999 Apr;10(2):111-9. doi: 10.1034/j.1600-0501.1999.100205.x.'}, {'pmid': '36162887', 'type': 'DERIVED', 'citation': 'Adly MS, Adly AS, Rasheed AM, Adly AS. CAN COMBINING LOW LEVEL LASER THERAPY WITH COMPUTER GUIDED FLAPLESS PIEZOSURGICAL OSTEOTOMY ACHIEVE A PAINLESS IMPLANT SURGERY? FINDINGS OF SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2022 Sep;22(3):101730. doi: 10.1016/j.jebdp.2022.101730. Epub 2022 Apr 18.'}, {'pmid': '26309133', 'type': 'DERIVED', 'citation': "Graziani F, Cei S, Orlandi M, Gennai S, Gabriele M, Filice N, Nisi M, D'Aiuto F. Acute-phase response following full-mouth versus quadrant non-surgical periodontal treatment: A randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):843-852. doi: 10.1111/jcpe.12451. Epub 2015 Oct 1."}, {'pmid': '26285807', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics.\n\nSpecific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease following surgical treatment of peri-implantitis.', 'detailedDescription': 'The study is designed as a randomized controlled clinical trial. 100 patients with severe peri-implantitis at one or more implants needing surgical treatment will be recruited. All individuals have to show unremarkable general health and not been using any antibiotics during the 6 months preceding the current examination.\n\nThe patients will be randomly assigned to the following :\n\n* test group (T) : surgical treatment with systemic antibiotics,\n* control group (C) : surgical treatment without systemic antibiotics. A stratification protocol will be applied regarding distribution of smokers. Two subgroups will be formed among test and control subjects.\n* saline group (T1 and C1) : the exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment, and,\n* antiseptics group (T2 and C2) : the exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine 0,2%) during the surgical treatment.\n\nA stratification protocol will be applied regarding distribution of smokers.\n\nFollowing the baseline examination, patients will randomly be assigned to the various treatment group. Samples from the subgingival microbiota will be obtained before surgical therapy.\n\nAll patients will be enrolled in a hygiene program including professional supragingival implant/tooth cleaning using rubber cups and polishing paste and oral hygiene instructions.\n\nThe following clinical parameters will be measured at baseline using a periodontal probe: plaque index, Bleeding on Probing, probing depth measured from the mucosal margin to the bottom of the probable pocket and mucosal recession measured from a fixed landmark on the implant to the mucosal margin.\n\nThe measurements will be made at 4 aspects of each implant. In the test group (T) a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient) Intra-oral radiographs will be taken at 2 weeks and 1 year after surgical therapy.\n\nThe professional implant/tooth cleaning and reinforcement of oral hygiene will be performed at 2 weeks, 1, 2, 3, 6, and 12 months after treatment.\n\nExamination of clinical outcome variables will be performed at 3, 6 and 12 months after surgical therapy. Microbiological samples will be obtained at the same time points. Radiographs are taken 2 weeks post surgical and at the one year examination.\n\nPrimary outcomes variables include: (i) clinical signs of resolution of peri-implantitis (pocket closure and absence of BoP), (ii) recurrence of the disease (BoP and increase in PPD) and (iii) further loss in marginal bone support, and (iiii) microbiological findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* peri-implant probing pocket depth \\> 7 mm on at least one aspect of the implant, together with BOP and/or suppuration,\n* marginal bone loss \\> 3mm as detected in radiographs.\n\nExclusion Criteria:\n\n* implant mobility,\n* peri-implantitis associated bone defects not suitable for pocket elimination therapy,\n* systemic diseases that could influence the outcome of the therapy,\n* penicillin allergy.'}, 'identificationModule': {'nctId': 'NCT01857804', 'briefTitle': 'Surgical Treatment of Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'olivier1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'antibiotics and local antiseptics', 'description': 'systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%', 'interventionNames': ['Drug: Amoxicillin', 'Drug: Chlorhexidine gluconate']}, {'type': 'EXPERIMENTAL', 'label': 'antibiotics without local antiseptics', 'description': 'systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline', 'interventionNames': ['Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'local antiseptics no antibiotics', 'description': 'no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2%', 'interventionNames': ['Drug: Chlorhexidine gluconate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no antibiotics and no local antiseptics', 'description': 'no systemic antibiotics + implant surface decontamination with saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'otherNames': ['systemic antibiotics'], 'description': 'In the test group a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient)', 'armGroupLabels': ['antibiotics and local antiseptics', 'antibiotics without local antiseptics']}, {'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'otherNames': ['chlorhexidine gluconate 0,2%'], 'description': 'The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment', 'armGroupLabels': ['antibiotics and local antiseptics', 'local antiseptics no antibiotics']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment', 'armGroupLabels': ['no antibiotics and no local antiseptics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40530', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Tord Berglundh, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}