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

Not Applicable

Active, not recruiting

• Conditions: Gingival Recession

• Registration Number: NCT02613702
• Lead Sponsor: University of Sao Paulo

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Reduced keratinized tissue (less than 2 mm) in inferior incisors area
• Healthy periodontium in inferior incisors area
• Indication for surgery (e.g. pain during tooth brushing, gingival margin mobility, gingival recession...)
• Recessions class I, II or III, maximum 3 mm
• Having signed the informed consent

Exclusion Criteria

• Systemic diseases
• Smokers
• Pregnant and lactating women
• Root caries lesions
• Previous surgeries at same area
• Accentuated root abrasion
• Malpositioning teeth
• Residual pocket depths greater than 4 mm
• Tooth mobility greater than 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Apical-cervical width of keratinized tissue after 12 months	12 months	Distance between gingival margin and mucogingival junction, in millimeters

Secondary Outcome Measures

Name	Time	Method
Volume of receiving area	12 months	Volume of receiving area
Postoperative discomfort	28 days	discomfort measured using Visual Analogue Scale
Probing Depth	12 months	Distance between gingival margin and bottom of the sulcus / pocket, in millimeters
Keratinized tissue thickness	12 months	Keratinized tissue thickness measured in millimeters
Complete epithelization of donor area	28 days	Area of Epithelization of wound healing, measured in mm2
Oral Health Related Quality of Life (OHIP)	12 months	OHIp - 14 short version
Clinical Attachment Level	12 months	Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters
Recession	12 months	Distance between cementum-enamel junction and gingival margin, measured in millimeters
Gum color	12 months	Measured with photographic analysis
Bleeding on probing	12 months	percentage of sites which bled upon probing
Keratinized tissue area	12 months	Keratinized tissue area, measured in millimeters

Trial Locations

Locations (1)

Faculdade de Odontologia da USP; 🇧🇷 São Paulo, SP, Brazil