Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT05688293
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2023-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "the patient won't know the type of the procedures done to him The outcome assessor won't know which group he the is assessing it's results"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three parallel groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-08', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-14', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival phenotype change', 'timeFrame': 'at baseline 3,6 and 12 months', 'description': 'determination of the change in gingival thickness in mm using periodontal probe'}], 'secondaryOutcomes': [{'measure': 'Keratinized tissue width', 'timeFrame': 'at baseline 3,6 and 12 months', 'description': 'determination of Keratinized tissue width in mm using periodontal probe'}, {'measure': 'Root coverage esthetic score (RES)', 'timeFrame': 'at baseline 3,6 and 12 months', 'description': 'It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.', 'detailedDescription': 'This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically free patients (American Society of Anesthesiologists I; ASA I)\n* Patients diagnosed with recession (RT1)\n* Fair oral hygiene\n* Patient accepting to provides an informed consent and the follow-up\n\nExclusion Criteria:\n\n* Carious teeth and teeth with periapical infection.\n* Patients diagnosed with periodontitis\n* Smokers\n* Pregnant and lactating females'}, 'identificationModule': {'nctId': 'NCT05688293', 'briefTitle': 'Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Misr International University'}, 'officialTitle': 'Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'PER 5213005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Connective tissue graft', 'description': 'Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique', 'interventionNames': ['Procedure: Connective tissue graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Free gingival Graft', 'description': 'Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft', 'interventionNames': ['Procedure: Free gingival graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non surgical procedure', 'description': 'Patients will receive non-surgical periodontal treatment only', 'interventionNames': ['Procedure: Non surgical']}], 'interventions': [{'name': 'Connective tissue graft', 'type': 'PROCEDURE', 'description': 'non-surgical periodontal treatment and connective tissue graft', 'armGroupLabels': ['Connective tissue graft']}, {'name': 'Free gingival graft', 'type': 'PROCEDURE', 'description': 'will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft', 'armGroupLabels': ['Free gingival Graft']}, {'name': 'Non surgical', 'type': 'PROCEDURE', 'description': 'non-surgical periodontal treatment only', 'armGroupLabels': ['Non surgical procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Zainab Hafez, Lecturer', 'role': 'CONTACT', 'email': 'zeinab.hafez@miuegypt.edu.eg'}, {'name': 'Yahia amer, Lecturer', 'role': 'CONTACT', 'email': 'yahia.hassan@miuegypt.edu.eg'}], 'facility': 'Faculty of oral and dental medicine, Misr international university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Zainab Hafez, Lecturer', 'role': 'CONTACT', 'email': 'zeinab.hafez@miuegypt.edu.eg', 'phone': '+01221334637'}, {'name': 'Shahinaz Al ashiry, Asso. Prof', 'role': 'CONTACT', 'email': 'shahinaz.elashiry@miuegypt.edu.eg'}], 'overallOfficials': [{'name': 'Zainab Hafez, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, faculty of oral and dental medicine misr international university'}, {'name': 'Shahinaz Al ashiry, Asso. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor, faculty of oral and dental medicine misr international university'}, {'name': 'Yahia Amer, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, faculty of oral and dental medicine misr international universit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}