Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-31 @ 9:43 PM
Study NCT ID:
NCT05563428
Status:
UNKNOWN
Last Update Posted:
2022-10-03
First Post:
2022-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Free Gingival Graft Versus Connective Tissue Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complete root coverage', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints.'}, {'measure': 'Mean root coverage', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. The MRC equals to the linear distance (in mm, using a probe) between the mid buccal point of the CEJ and the mid-buccal sulcus at baseline, divided by the distance between the mid buccal point of the CEJ and the mid buccal sulcus. The MRC will be measured as percentage (%)'}, {'measure': 'Keratinized tissue height', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Defined as the linear height of keratinized tissue, measured between the mid-buccal sulcus of the treated tooth and the muco-gingival junction (in mm using a probe). It will be measured at baseline and at the different timepoints.'}, {'measure': 'Recession reduction', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'defined as the linear reduction in recession (in mm using a probe), at the mid buccal aspect, between baseline and the different timepoints.'}, {'measure': 'Gingival thickness', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'evaluated at baseline using couloured paperpoints inserted into the sulcus.'}, {'measure': 'CAL', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'defined as the change in Clinical Attachement of the gingival margin, measured linearly at the mid-buccal aspect, from the JEC to the bottom of the pocket, at the different timepoints.'}, {'measure': 'PPD changes', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'defined as the change in depth of the pocket, measured at the mid-buccal aspect using a probe, between baseline and the different timepoints. It will be measured at the different timepoints.'}, {'measure': 'Dental hypersensitivity', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Assessed by 10 s air spray applied to the buccal cervical area (yes/no).'}, {'measure': 'Root coverage esthetic score', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Evaluated at the different timepoints according to Cairo et al. (2009).'}, {'measure': 'Biological complications reported by the investigators', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Biological complications reported by the investigators'}, {'measure': 'Digital complete root coverage', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints, analyzed digitally'}, {'measure': 'Digital recession reduction', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'defined as the reduction in recession (in mm², measured digitally), at the mid buccal aspect, between baseline and the different timepoints. It will be measured at the different timepoints.'}, {'measure': 'Digital Keratinized Tissue Height', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Defined as the changes in keratinized tissue surface (surface delimited mesio-distally by the perpendicular projection of a line passing by the contact-point and apico-coronally by the muco-gingival junction and the gingival margin, at the mid-buccal aspect of the tooth.'}, {'measure': 'Digital gingival soft tissue profile', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Defined as the change in gingival soft tissue thickness between baseline and the different timepoints, measured at the mid buccal aspect, between baseline and the different timepoints.'}], 'primaryOutcomes': [{'measure': 'Digital mean root coverage', 'timeFrame': 'Baseline, 3 months, 6 months and up to 10 years after surgery', 'description': 'Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival recession', 'Free gingival graft', 'Connective tissue graft'], 'conditions': ['Gingival Recession', 'Gingival Recession, Localized']}, 'descriptionModule': {'briefSummary': 'This study wil compare FGG and CTG for recession coverage in the anterior mandibula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA type I and II subjects\n* Localized Gingival Recessions\n* Recessions Cairo RT I-II-III\n* FMPS \\< 10%\n* FMBS\\< 10%\n* \\<10 cigs/ day\n* No contra-indication against oral surgical interventions\n* Patient is able to give inform consent\n\nExclusion Criteria:\n\n* Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.\n* ASA type \\> II\n* Current pregnancy or breastfeeding women\n* Alcoholism or chronically drug abuse\n* Smokers, ≳ 10 cigarettes per day\n* Immunocompromised patients\n* Uncontrolled diabetes\n* Untreated periodontitis\n* History of previous periodontal surgery (mucogingival or other) on the teeth to be included\n* Presence of severe tooth malposition, rotation or significant version of the tooth to be treated\n* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability'}, 'identificationModule': {'nctId': 'NCT05563428', 'briefTitle': 'Free Gingival Graft Versus Connective Tissue Graft', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Liege'}, 'officialTitle': 'Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT', 'orgStudyIdInfo': {'id': '2021-242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Free gingival graft', 'description': 'Free gingival graft will be conducted.', 'interventionNames': ['Procedure: Free gingival graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Connective tissue graft', 'description': 'The recession will be treated with the pouch technique using a connective tissue graft.', 'interventionNames': ['Procedure: Connective tissue graft']}], 'interventions': [{'name': 'Free gingival graft', 'type': 'PROCEDURE', 'description': 'A free gingival graft will be carried out for recession treatment.', 'armGroupLabels': ['Free gingival graft']}, {'name': 'Connective tissue graft', 'type': 'PROCEDURE', 'description': 'The pouch technique with a connective tissue graft will be carried out for recession treatment.', 'armGroupLabels': ['Connective tissue graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Gilles Szotek, MsC', 'role': 'CONTACT'}], 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'France Lambert, PhD', 'role': 'CONTACT', 'email': 'france.lambert@chuliege.be', 'phone': '+32 4 270 31 05'}, {'name': 'Isabelle Laleman, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Szoted Gilles, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ULiège'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chef de clinique', 'investigatorFullName': 'Isabelle Laleman', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Liege'}}}}