Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession
- Conditions
- Gingival Recession, Localized
- Registration Number
- NCT06553677
- Lead Sponsor
- Cairo University
- Brief 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.
- Detailed Description
Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini \& Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli \& Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.
(Barootchi \& Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and 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. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve 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.
So, this clinical trial aims to address this gap of the literature.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
- Patients age 18 years or older.
- Isolated recession defect classified as RT2.
- Patients with healthy systemic condition.
- Clinical indication and/or patient request for root coverage.
- O'Leary index less than 20%.
- Pregnant females
- Smokers: a contraindication for any plastic periodontal surgery.
- Unmotivated and uncooperative patients with poor oral hygiene
- Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Gingival Recession Depth 6 months It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.
- Secondary Outcome Measures
Name Time Method Percentage of mean root coverage (MRC%) 6 months (Preoperative vertical recession depth - Postoperative vertical recession/preoperative vertical recession) x 100 \[%\]
Gingival Thickness 6 months Measured using transgingival needle probing using anesthesic needle a rubber stopper
Pink Esthetic Score 6 months 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.Percentage of complete root coverage (CRC%) 6 months Number of defect sites with complete root coverage/ Total number of recession sites treated x 100 \[%\]
Clinical Attachment Level 6 months Measured from the CEJ to the bottom of the gingival sulcus.
Post-operative patient satisfaction 2 weeks, 6 months 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.
Gingival Recession Width 6 months Measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth)
Keratinized Tissue Width 6 months Measured as the distance between the gingival margin and the mucogingival junction (MGJ).
Post-operative pain 2 weeks 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.
Probing Pocket Depth 6 months Measured from the gingival margin to the bottom of the gingival sulcus.
Root coverage esthetic score 6 months (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
Trial Locations
- Locations (1)
Faculty of Dentistry, Cairo University
🇪🇬Cairo, Egypt
Faculty of Dentistry, Cairo University🇪🇬Cairo, Egypt