Comparative Effectiveness of Titanium Platelet-Rich Fibrin and Connective Tissue Graft Harvested from the Tuberosity Area Via Modified Vestibular Incision Supraperiosteal Tunnel Access for Managing Gingival Recession: Protocol for a Randomized Controlled Trial.

Abstract

Background: Periodontal surgery has traditionally relied on connective tissue grafts (CTGs) obtained from the tuberosity site to correct gingival recession abnormalities. However, there are challenges to be addressed, including insufficient graft quantity and patient susceptibility. Consequently, titanium-prepared platelet-rich fibrin, or T-PRF, has emerged as a competitive alternative. By combining T-PRF with the modified vestibular incision supraperiosteal tunnel access (M-VISTA) approach, a more conservative way is provided, which may improve the course of treatment.

Objective: The objective of this study is to compare the effectiveness of T-PRF and CTGs from the tuberosity area in managing gingival recession defects using the M-VISTA technique. The study aims to evaluate improvements in clinical outcomes, including pocket probing depth (PPD), clinical attachment level (CAL), relative gingival margin level (RGML), recession depth (RD), and width of keratinized gingiva (WKG), as well as plaque and bleeding indices.

Methods: The proposed methodology entails conducting a randomized clinical trial over 2 years with 24 participants, each presenting with multiple gingival recessions (>2 mm, Miller's Class I or II) on the buccal or labial aspects of teeth in the maxilla or mandible. Participants will be randomly allocated into 2 groups: the test group and the control group. The M-VISTA technique will be used for root coverage using T-PRF in the test group and tuberosity CTG in the control group as regenerative materials. Their effectiveness will be compared by evaluating PPD, CAL, RGML, RD, and WKG. Additionally, the plaque index will be calculated by dividing the total plaque index score of all teeth by the number of teeth examined, and the papillary bleeding index will be assessed using a periodontal probe with scores evaluated on a scale of 0-4 based on bleeding potential. Data will be analyzed using Student paired and unpaired t tests to compare results from baseline to 3 and 6 months for each group.

Results: Recruitment, participant selection, baseline data collection, and randomization of groups concluded in September 2024, and the intervention phase is scheduled to end in December 2025. The study is expected to be completed by July 2026, with final evaluation, data analysis, and publication preparation taking place between June and July 2026.

Conclusions: Based on existing evidence, we anticipate that the M-VISTA technique with T-PRF will provide superior root coverage compared to tuberosity CTG because no second surgical site is involved. Evidence suggests that T-PRF may offer comparable clinical benefits to CTG, particularly in clinical attachment gain, RD reduction, and gingival thickness, supporting the advancement of minimally invasive periodontal plastic surgery.

Trial registration: Clinical Trials Registry of India CTRI/2024/07/071619; https://tinyurl.com/ypfe34b5.

International registered report identifier (irrid): DERR1-10.2196/67168.