Clinical trial NCT06504329: Recession Coverage Using Modified Coronally Advanced Tunnel(MCAT)
Official title: Recession Coverage Using Modified Coronally Advanced Tunnel With Connective Tissue Graft and With or Without Enamel Matrix Derivative: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival recession
modified coronally advanced tunnel
enamel matrix derivative
subepithelial connective tissue graft
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In our study, patients with Miller Class I and II gingival recession will be divided into three groups to undergo the modified coronally advanced tunnel (MCAT) technique using connective tissue grafts, enamel matrix derivatives, or a combination of connective tissue grafts and enamel matrix derivatives. The short- and long-term success of these groups will be evaluated. There are limited studies on the MCAT technique in the literature, and our objectives and anticipated outcomes upon completion of the project are as follows:

1. Evaluation of the success of the MCAT technique in root coverage.
2. Evaluation of the aesthetic outcomes of the MCAT technique.
3. Evaluation of the impact of the MCAT technique on postoperative patient comfort and morbidity.
4. Assessment of the effect of enamel matrix derivative (Emdogain) application on treatment outcomes.
5. Assessment of the effect of connective tissue graft on treatment outcomes.
6. Investigation of the additional benefits of combining connective tissue grafts with enamel matrix derivatives.
7. Evaluation of the long-term outcomes of gingival recession treatment.

By focusing on these goals, the investigators aim to provide comprehensive insights into the efficacy and benefits of the MCAT technique and its variations in treating gingival recession.

Detailed description: This study is planned to be conducted with 60 individuals, aged between 18 and 45, who have presented to the Department of Periodontology at Necmettin Erbakan University Faculty of Dentistry for various reasons. Routine initial periodontal examinations and Phase 1 periodontal treatments will be performed on individuals exhibiting gingival recession and associated sensitivity. Standard mucogingival surgical procedures are routinely applied in our faculty to these individuals.

In our study, the short- and long-term outcomes of the MCAT technique, a mucogingival approach, will be evaluated. The study will consist of the following three groups:

Group 1: Modified coronally advanced tunnel (MCAT) + subepithelial connective tissue graft (n:20) Group 2: Modified coronally advanced tunnel (MCAT) + enamel matrix derivative(n:20) Group 3: Modified coronally advanced tunnel (MCAT) + subepithelial connective tissue graft + enamel matrix derivative(n:20)

Our study is designed as a randomized, controlled clinical trial. Measurements will include gingival thickness, the amount of root coverage, and keratinized gingiva parameters, recorded using a Williams probe (Hu-Friedy) and rounded to the nearest millimeter.

For gingival recession, plaque index, and gingival index will be obtained from three points: mesial, distal, and midpoints. The plaque index will be calculated according to the criteria defined by Silness and Loe, while the gingival index will be assessed based on the criteria defined by Loe and Silness. Gingival thickness will be measured 3 mm below the gingival margin under topical anesthesia using an endodontic reamer with a stopper.

Patients will be asked to complete a chart rating their subjective pain, burning sensation, and discomfort in the surgical area on a visual analogue scale (VAS) ranging from 0 (none) to 100 (very severe) on postoperative days 3 and 7. The clinician will remove the sutures two weeks after surgery and will complete the wound healing index for each tooth individually according to Huang's criteria.

This study aims to provide comprehensive insights into the effectiveness and benefits of the MCAT technique and its variations in treating gingival recession.

Eligibility criteria: Inclusion Criteria:

* Volunteers aged between 18-45 years.
* No previous surgical procedures should have been performed in the selected areas.
* Presence of periodontal pockets not exceeding 3 mm in treated teeth; absence of occlusal trauma.
* Not being pregnant or breastfeeding, and not undergoing any regulatory drug treatment.
* Patients presenting with various periodontal problems who have received indications for modified coronally advanced tunnel due to gingival recession in the periodontology clinic.
* Absence of any systemic condition that could interfere with surgical procedures.

Exclusion Criteria:

* Exclusion criteria and refusal to participate in the study.

Primary outcomes:
measure: Measurement of Preoperative Periodontal Parameters and Taking Initial Photographs
timeFrame: Preoperatively, before the start of treatment.
Secondary outcomes:
measure: Measurement of Periodontal Parameters and Taking Photographs at 1, 3, and 6 Months Post-Operation
timeFrame: 1, 3, and 6 months post-operation.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of Dentistry
Study officials:
References: