NCT06650072

Effectiveness of Tuberosity Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

Palatal vs Tuberosity Micro-connective Tissue Grafts for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Controlled Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG, and to evaluate the outcomes in both the donor and recipient sites.

Detailed description

A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage. CTGs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity, due to the high amount of lamina propria and minimal submucosal tissue (adipose and glandular tissue). When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. Modification of the harvested CTG into multiple "micro-CTG" has been proposed for the treatment of multiple adjacent GRDs (MAGRD) in order to reduce the amount of CTG to be harvested. Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest, are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications, resulting in reduced patient morbidity. However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients. The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain, oral health-related quality of life (OHRQoL), degree of root coverage and esthetic outcomes. The investigators hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months (non-inferiority). Subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

Conditions

• Gingival Recession, Localized

Interventions

Type	Name	Description
PROCEDURE	modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts	The connective tissue graft will be harvested from the palate.
PROCEDURE	modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts	The connective tissue graft will be harvested from the maxillary tuberosity.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-10-21
• Last updated: 2025-03-12