Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
- Conditions
- Gingival Recession
- Interventions
- Procedure: Free Gingival GraftProcedure: Original Free Gingival Graft techniqueProcedure: Modified Free Gingival Graft technique
- 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 and 12 months after surgeries.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
- Arm && Interventions
Group Intervention Description Modified Free Gingival Graft Free Gingival Graft 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. Original Free Gingival Graft technique Free Gingival Graft Twenty patients will receive the original technique of free gingival graft at the inferior incisors area. Original Free Gingival Graft technique Original Free Gingival Graft technique Twenty patients will receive the original technique of free gingival graft at the inferior incisors area. Modified Free Gingival Graft Modified Free Gingival Graft technique 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.
- 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
Gum color 12 months Measured with photographic analysis
Postoperative discomfort 28 days discomfort measured using Visual Analogue Scale
Keratinized tissue area 12 months Keratinized tissue area, measured in millimeters
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
Bleeding on probing 12 months percentage of sites which bled upon probing
Trial Locations
- Locations (1)
Faculdade de Odontologia da USP
🇧🇷São Paulo, SP, Brazil