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NOT YET RECRUITING
NCT07854132
NA

Comparison of the Keratinized Tissue Gain in Frenal Relocation Alone to Frenal Relocation Combined With the Application of Free Gingival Graft in High Frenum Attachment in Adults

Sponsor: October University for Modern Sciences and Arts

View on ClinicalTrials.gov

Summary

The goal of this randomized clinical study is to compare in Adults Clinical Effect of Frenal Relocation without Free Gingival Graft Application on Keratinized Tissue Gain When Compared to Frenal Relocation with Free Gingival Graft Application. The main question aims to answer: In Adults with high frenum attachment, will frenal relocation alone show a difference or enhance the keratinized tissue gain compared to frenal relocation procedure combined with the application of a free gingival graft?

Official title: The Clinical Comparison of the Keratinized Tissue Gain in Frenal Relocation Alone to Frenal Relocation Combined With the Application of Free Gingival Graft in High Frenum Attachment: A Randomized Clinical Study

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2026-09-30

Completion Date

2027-06-30

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

PROCEDURE

Frenotomy

1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The epithelium will be sutured to the underlying periosteum using three interrupted periosteal 6-0 resorbable sutures and left to heal by secondary intention.

PROCEDURE

Frenotomy with Free Gingival Graft

1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The desired size of the graft will be determined using a template and a free gingival graft will be harvested from the palate. 5. The graft will then be positioned and adapted firmly by suturing to the periosteum at the recipient site using 6-0 resorbable sutures. 6. The epithelium will be then sutured to the underlying periosteum using three interrupted periosteal 6-0 sutures and left to heal by secondary intention.

Locations (1)

October University for Modern Sciences and Arts

Giza, Egypt