Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-29 @ 6:13 AM
Study NCT ID:
NCT07064603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of (TCAF) Versus (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival recession depth reduction (GRD)', 'timeFrame': 'ONE YEAR'}], 'secondaryOutcomes': [{'measure': 'Percentage of mean root coverage (MRC %)', 'timeFrame': 'one year'}, {'measure': 'Percentage of complete root coverage (CRC%)', 'timeFrame': 'one year'}, {'measure': 'Gingival Recession width', 'timeFrame': 'one year'}, {'measure': 'Keratinized tissue width (KTW)', 'timeFrame': 'one year'}, {'measure': 'Probing pocket depth', 'timeFrame': 'one year'}, {'measure': 'Root coverage esthetic score', 'timeFrame': 'one year', 'description': '10 is the ideal esthetic score\n\nZero points will be assigned if the final position of the gingival margin is equal or apical to the previous recession depth (failure of root coverage procedure), irrespective of color, the presence of a scar, MTC, or MGJ.\n\nZero points will also be assigned when a partial or total loss of interproximal papilla (black triangle) occurred following the treatment'}, {'measure': 'Volumetric soft tissue changes', 'timeFrame': 'one year'}, {'measure': 'Post-operative pain', 'timeFrame': '2 Week post-operative', 'description': "Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively"}, {'measure': 'Post-operative patient satisfaction', 'timeFrame': 'one year', 'description': 'A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole surgical procedure and the achieved results of the procedure performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Plastic Surgery']}, 'descriptionModule': {'briefSummary': 'the aim of the study is to evaluate the changes in gingival recession depth reduction following, treatment of multiple RT2 recession with tunnel coronal advanced flap in comparison to coronal advanced flap, both combined with connective tissue graft', 'detailedDescription': 'Several techniques for gingival recession defects have been developed for treatment such as are pedicle soft-tissue graft (rotational flap procedures, advanced flap procedure and tunneling), free soft-tissue graft (epithelialized and subepithelial connective tissue graft) and regenerative procedures (barrier membrane or biologic mediators.\n\nThe coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. Barootchi et al. 2024 conducted a clinical study using tunnel coronal advanced flap technique(TCAF) for treating multiple RT2 gingival recession defects ,in order to combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. From the previous study it was concluded that the combination of both techniques in the same surgical design can improve both the flap and graft vascularization and enhance clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction in multiple RT2 recessions.\n\nSo, this clinical trial aims to address this gap of the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients age 18 years or older.\n* Multiple adjacent recession defect classified as RT2.\n* Patients with healthy systemic condition (Mazzotti et al., 2023).\n* An esthetic concern or hypersensitivity associated with GR\n* The gingival recessions must have at least 1.5 mm of KTW.\n* Presence of an identified CEJ (A step ≤ 1mm of the CEJ level)\n\nExclusion Criteria:\n\n* Full-mouth plaque and bleeding scores \\>20 (O'Leary et al., 1972)\n* Patients with active periodontal disease;\n* Intake of any medications known to affect gingival homeostasis or to interfere with wound healing\n* Pregnancy and nursing women\n* Smokers: a contraindication for any plastic periodontal surgery (Khuller, 2009).\n* Absence of cervical restorations, crowding or malalignment"}, 'identificationModule': {'nctId': 'NCT07064603', 'briefTitle': 'Clinical Evaluation of (TCAF) Versus (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Multiple RT2 Gingival Recession Sites: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2025-17-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT', 'description': 'The surgical papillae will be elevated using split thickness manner while maintaining the blade in a nearly parallel position to the root.\n\n* The flap apical to the exposed root will be elevated in a full-thickness The full thickness flap covers the avascular root exposure.\n* The releasing vertical incisions will be elevated protect the underlying bone in the lateral areas of the flap.\n* The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction.\n* To permit the coronal advancement of the flap, all muscle insertions present in the thickness of the flap will be eliminated. This will be done by keeping the blade parallel to the external mucosal surface.\n\nThe connective tissue graft, is harvested from the hard palate (donor site) then it will be sutured in the surgical recipient site then covered by the coronal advancement of the flap and suturing it.', 'interventionNames': ['Procedure: TCAF']}, {'type': 'EXPERIMENTAL', 'label': 'Tunnel coronal advanced flap with connective tissue graft', 'description': 'only one surgical papilla will be elevated. The papilla chosen for incision must be with the least interproximal attachment loss. A slightly divergent vertical incision extending beyond the mucogingival junction then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip. The other papillae integrity is preserved , and will be detached using tunneling miniblades and papilla elevator. The flap will be tunneled till the planned papilla .Connective tissue graft will be harvested the graft will be inserted underneath the flap and tunneled below the non-incised papillae. The TCAF is coronally advanced and stabilized 2 mm above the CEJ with sling and simple interrupted sutures at the level of the papillae and simple interrupted sutures for the vertical incision Further coronal advancement of the tunneled papilla with a suspended suture around the with a composite stop', 'interventionNames': ['Procedure: TCAF']}], 'interventions': [{'name': 'TCAF', 'type': 'PROCEDURE', 'description': 'tunnel coronal advanced flap', 'armGroupLabels': ['CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT', 'Tunnel coronal advanced flap with connective tissue graft']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'May Mohamed Kamal', 'role': 'CONTACT', 'email': 'may.kamal@dentistry.cu.edu.eg', 'phone': '01063392983'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'may mohamed kamal', 'investigatorAffiliation': 'Cairo University'}}}}