Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 5:40 PM
Study NCT ID:
NCT04254406
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2020-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ten Years Follow up of Peri-implant Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-02', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-02-02', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number patients with persisting peri-implantitis following peri-implant surgery', 'timeFrame': '10 years', 'description': 'The total number of patients with persisting peri-implantitis will be calculated. Any subject presenting at least one implants with a pathological pocket will be regarded as positive for the disease .\n\nThe presence or absence of peri-implantitis will be assessed by using a periodontal probe around the mucosa of the implants.\n\nThe definition of a pathological pocket around an implant is a pocket of 5 millimeters or more deep with concomitants bleeding after the use of the probe.'}, {'measure': 'Percentage of subjects with persisting peri-implantitis', 'timeFrame': '10 years', 'description': 'The percentage of patients with persisting peri-implantitis following peri-implantitis surgery will be calculated among all the patients that were treated.\n\nFor definition of peri-implantitis see description at outcome 1.'}, {'measure': 'Number of implant with persisting peri-implantitis', 'timeFrame': '10 years', 'description': 'The number of implants with persisting clinical signs of peri-implantitis will be calculated. Any implant presenting a pathological pockets around its surface will be regarded as positive for the disease.\n\nFor definition of peri-implantitis see description at outcome 1'}, {'measure': 'Percentage of implants wih persisting peri-implantitis', 'timeFrame': '10 years', 'description': 'The percentage of implants with persisting peri-implantitis after surgery will be calculated among all the implants that were surgically treated.\n\nFor definition of peri-implantitis see description at outcome 1'}], 'secondaryOutcomes': [{'measure': 'Assessement of risk factors related to the persistence of peri-implantitis', 'timeFrame': '10 years', 'description': 'A univariate logistic regression to assess the correlations between each independent variable and the binary outcome presence or absence of peri-implantitis at treated implants will be used. Then, a multivariable regression analysis will be use including the independent variables from the univariate analysis that reach a statistical significance after adjusting for gender and age.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-Implantitis surgery', 'Treatment outcome', 'Risk factors'], 'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '27335316', 'type': 'RESULT', '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': '24861154', 'type': 'RESULT', 'citation': 'Serino G, Turri A, Lang NP. Maintenance therapy in patients following the surgical treatment of peri-implantitis: a 5-year follow-up study. Clin Oral Implants Res. 2015 Aug;26(8):950-956. doi: 10.1111/clr.12418. Epub 2014 May 26.'}, {'pmid': '21309860', 'type': 'RESULT', 'citation': 'Serino G, Turri A. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans. Clin Oral Implants Res. 2011 Nov;22(11):1214-20. doi: 10.1111/j.1600-0501.2010.02098.x. Epub 2011 Feb 11.'}, {'pmid': '30328195', 'type': 'RESULT', 'citation': 'Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287.'}, {'pmid': '29926491', 'type': 'RESULT', 'citation': 'Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.'}, {'pmid': '23237584', 'type': 'RESULT', 'citation': 'Lagervall M, Jansson LE. Treatment outcome in patients with peri-implantitis in a periodontal clinic: a retrospective study. J Periodontol. 2013 Oct;84(10):1365-73. doi: 10.1902/jop.2012.120555. Epub 2012 Dec 13.'}, {'pmid': '22530771', 'type': 'RESULT', 'citation': 'Pjetursson BE, Helbling C, Weber HP, Matuliene G, Salvi GE, Bragger U, Schmidlin K, Zwahlen M, Lang NP. Peri-implantitis susceptibility as it relates to periodontal therapy and supportive care. Clin Oral Implants Res. 2012 Jul;23(7):888-94. doi: 10.1111/j.1600-0501.2012.02474.x. Epub 2012 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'To report 10-years follow up of patients following the surgical treatment of peri-implantitis and to identify possible risk indicators for the progression of disease during supportive peri-implant therapy.', 'detailedDescription': 'The data for this retrospective clinical evaluation were collected from the files and radiographs of consecutive patients who had received surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT) .\n\nBetween 2007 and 2009, 41 patients with at least 1 implant with peri-implantitis that underwent peri-implant surgery were enrolled in a supportive peri-implant therapy.\n\nAt the 2-years follow up, two groups could be identified, one "responding group" (17 patients) who did not present any implants with peri-implantitis and a "no-responding Group" (22 patients), presenting still peri-implantitis.\n\nFollowing the 2-years control visit, 17 patients of the responding group exited the supporting peri-implant therapy at the specialist clinic. They continued the routine controls at their referral clinics while the 22 patients of the no-responding group, continued the scheduled supportive peri-implant therapy (SPT) given at the specialist clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients who had received routine surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All patients treated with peri-implantitis surgery between 2007 and 2009 using an anti-infective protocol.\n\nExclusion Criteria:\n\n* Patients treated with peri-implantitis surgery between 2007 and 2009 using a regenerative protocol at one single implants with peri-implantitis.'}, 'identificationModule': {'nctId': 'NCT04254406', 'briefTitle': 'Ten Years Follow up of Peri-implant Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Public Dental Service, Specialist Clinics, Sweden'}, 'officialTitle': '10 Years Follow-up of Patients With Residual Pockets Following the Surgical Treatment of Peri-implantitis', 'orgStudyIdInfo': {'id': 'PDSSweden'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Descriptive study', 'type': 'OTHER', 'description': 'Evaluation of routine treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50182', 'city': 'Borås', 'country': 'Sweden', 'facility': 'Giovanni Serino', 'geoPoint': {'lat': 57.72101, 'lon': 12.9401}}], 'overallOfficials': [{'name': 'Giovanni Serino, DDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Folktanvarden Specilist Clinic Periodntology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After publication, on request, summary data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Dental Service, Specialist Clinics, Sweden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osaka University Japan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Periodontology', 'investigatorFullName': 'Giovanni Serino', 'investigatorAffiliation': 'Public Dental Service, Specialist Clinics, Sweden'}}}}