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

University of Sao Paulo

Status: Active, not recruiting

Conditions: Gingival Recession

Treatments: Procedure: Original Free Gingival Graft technique; Procedure: Modified Free Gingival Graft technique; Procedure: Free Gingival Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT02613702

EFFECT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Modified Free Gingival Graft

Experimental group

Description:

Twenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery.

Treatment:

Procedure: Modified Free Gingival Graft technique

Procedure: Free Gingival Graft

Original Free Gingival Graft technique

Active Comparator group

Description:

Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.

Treatment:

Procedure: Free Gingival Graft

Procedure: Original Free Gingival Graft technique