Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession
NCT Number: NCT06553677
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Recession, Localized
Interventions: PROCEDURE: Tunneled coronal advanced flap with connective tissue graft|PROCEDURE: Coronally advanced flap with connective tissue graft
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-09
Locations: Faculty of Dentistry, Cairo University, Cairo, Egypt

Summary:
The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.

Primary Outcome Measures: Gingival Recession Depth, It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe., 6 months
Secondary Outcome Measures: Percentage of mean root coverage (MRC%), (Preoperative vertical recession depth - Postoperative vertical recession/preoperative vertical recession) x 100 \[%\], 6 months|Percentage of complete root coverage (CRC%), Number of defect sites with complete root coverage/ Total number of recession sites treated x 100 \[%\], 6 months|Gingival Recession Width, Measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth), 6 months|Gingival Thickness, Measured using transgingival needle probing using anesthesic needle a rubber stopper, 6 months|Keratinized Tissue Width, Measured as the distance between the gingival margin and the mucogingival junction (MGJ)., 6 months|Clinical Attachment Level, Measured from the CEJ to the bottom of the gingival sulcus., 6 months|Probing Pocket Depth, Measured from the gingival margin to the bottom of the gingival sulcus., 6 months|Pink Esthetic Score, It's a score by (Fürhauser et al., 2005) based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture.

Each variable is assessed with a 0-1-2 score, with 2 being the best and 0 being the poorest score., 6 months|Post-operative pain, 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., 2 weeks|Post-operative patient satisfaction, 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., 2 weeks, 6 months|Root coverage esthetic score, (Cairo et al., 2009) This score evaluates five variables: level of the gingival margin (GM) , marginal tissue contour (MTC), soft tissue texture (STT) , mucogingival junction (MGJ) alignment , and gingival color (GC).

* GM: Zero point for failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points partial root coverage; 6 points CRC.
* MTC: Zero point irregular gingival margin (does not follow the CEJ); 1 point -proper marginal contour/ scalloped gingival margin (follows the CEJ).
* STT: Zero point for scar formation and/or keloid-like appearance; I point absence of scar or keloid formation.
* MGJ: Zero point -MGJ not aligned with the MGJ of adjacent teeth; 1 point if the MGJ aligned with the MGJ of adjacent teeth.
* GC: Zero point color of tissue varies from gingival color at adjacent teeth; 1 point normal color and integration with the adjacent soft tissues.

  10 is the ideal esthetic score, 6 months