NCT05717985

Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the de-epithelized gingival graft (control group) and modified combined approach for connective tissue graft (test group) in patients undergoing palatal graft harvesting for mucogingival surgery in the oral cavity

Detailed description

Harvesting a palatal mucosal tissue graft as an autologous donor for oral soft tissue augmentation is widely practiced. Tissue harvest in patients with anatomically thin phenotypes can cause significant morbidity and compromised healing process. The modified combined approach (MCA) for connective tissue grafts has the potential for faster healing and fewer postoperative complications, compared to the recommended harvesting technique of de-epithelized gingival graft (DGG). However, the modified combined approach for connective tissue grafts have yet to be extensively investigated. This examiner-masked, randomized study aims to compare post-operative morbidity and treatment outcomes in patients undergoing modified combined approach for connective tissue graft (test group) compared to the de-epithelized gingival graft (control group) harvesting techniques in tissue augmentation. Participants will be randomized into two groups receiving one of either modified combined approach for connective tissue graft or de-epithelized gingival graft. Collection of the study parameters will utilize both examiner-assessed, and patient reported outcomes. The study will report on the optimum palatal mucosal graft harvesting technique in an Asian population. The findings of this study will be utilized to formulate clinical recommendations for soft tissues augmentation in this population.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	modified combined approach	A thin layer of epithelium will be excised from the harvested graft. This epithelium will be replaced at the donor site and sutured.
PROCEDURE	de-epithelized gingival graft	Only dressing material will be placed at the donor site after graft harvesting

Timeline

• Start date: 2023-02-22
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2023-02-08
• Last updated: 2024-12-02

Locations

1 site across 1 country: Malaysia