NCT02613702

Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.

Detailed description

The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	Free Gingival Graft	Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
PROCEDURE	Original Free Gingival Graft technique	Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area
PROCEDURE	Modified Free Gingival Graft technique	Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area

Timeline

• Start date: 2015-09-01
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2015-11-24
• Last updated: 2025-05-25

Locations

1 site across 1 country: Brazil