Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-05 @ 1:33 AM
Study NCT ID:
NCT03037320
Status:
UNKNOWN
Last Update Posted:
2017-02-01
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of root coverage', 'timeFrame': '6 months', 'description': 'root coverage in millimeters'}], 'secondaryOutcomes': [{'measure': 'width of keratinised gingiva', 'timeFrame': '6 months', 'description': 'increase of width measured in millimeters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Generalized', 'Root Coverage']}, 'descriptionModule': {'briefSummary': 'Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.', 'detailedDescription': 'the subjects attending the OPD department of periodontology, IGIDS and patients will be selected based on inclusion criteria, informed consent to be obtained from the patients,\n\nRandomization process:\n\n1. Patient to be selected for one of the two procedures by simple random sampling (Lottery method)\n2. Baseline value will be recorded by a calibrated examiner other than the operator\n3. The procedure is performed by the operator ( primary investigator)\n4. Post op values to be recorded by the calibrated examiner.\n\nPatient to be reviewed at 3 and 6 months Results will be dicussed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females subjects of 20-50 years.\n* Patients with multiple gingival recession (2-4 teeth) of class I \\& II in maxillary teeth.\n* Patients with well aligned teeth\n\nExclusion Criteria:\n\n* Patients with class III \\&IV gingival recession in maxillary teeth\n* Recession in relation to molars\n* Patients with systemic diseases\n* Medically compromised patients\n* Patient with history of smoking\n* Patients with erosion and root caries'}, 'identificationModule': {'nctId': 'NCT03037320', 'acronym': 'CAF and SVIT', 'briefTitle': 'Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Indira Gandhi Institute of Dental Science'}, 'officialTitle': 'Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled', 'orgStudyIdInfo': {'id': 'IGIDSIEC2016NDP28PGHPPAI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'root coverage to be performed by semilunar vestibular incision technique', 'interventionNames': ['Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth']}, {'type': 'OTHER', 'label': 'group B', 'description': 'root coverage by coronally advanced flap', 'interventionNames': ['Procedure: comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth']}], 'interventions': [{'name': 'comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth', 'type': 'PROCEDURE', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '607402', 'city': 'Puducherry', 'state': 'Puducherry', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Hema pichandi, BDS', 'role': 'CONTACT', 'email': 'drhema6119@gamil.com', 'phone': '9442804426', 'phoneExt': '+91'}, {'name': 'Pratebha Balu, MDS', 'role': 'CONTACT', 'email': 'pratebhabalu@igids.ac.in', 'phone': '9894360543', 'phoneExt': '+91'}], 'facility': 'Indira Gandhi Institute of dental sciences', 'geoPoint': {'lat': 11.93381, 'lon': 79.82979}}], 'centralContacts': [{'name': 'Hema pichandi, BDS', 'role': 'CONTACT', 'email': 'drhema6119@gmail.com', 'phone': '9442804426', 'phoneExt': '+91'}, {'name': 'Pratebha Balu, MDS', 'role': 'CONTACT', 'email': 'pratebhabalu@igids.ac.in', 'phone': '9894360543', 'phoneExt': '+91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indira Gandhi Institute of Dental Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'post graduate student', 'investigatorFullName': 'Dr.Hema.P', 'investigatorAffiliation': 'Indira Gandhi Institute of Dental Science'}}}}