Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Apical-cervical width of keratinized tissue after 12 months
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Modified 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.
Intervention: Free Gingival Graft (Procedure)
Modified 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.
Intervention: Modified Free Gingival Graft technique (Procedure)
Original Free Gingival Graft technique
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Intervention: Free Gingival Graft (Procedure)
Original Free Gingival Graft technique
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Intervention: Original Free Gingival Graft technique (Procedure)
Outcomes
Primary Outcomes
Apical-cervical width of keratinized tissue after 12 months
Time Frame: 12 months
Distance between gingival margin and mucogingival junction, in millimeters
Secondary Outcomes
- Gum color(12 months)
- Postoperative discomfort(28 days)
- Probing Depth(12 months)
- Keratinized tissue area(12 months)
- Keratinized tissue thickness(12 months)
- Volume of receiving area(12 months)
- Complete epithelization of donor area(28 days)
- Oral Health Related Quality of Life (OHIP)(12 months)
- Clinical Attachment Level(12 months)
- Recession(12 months)
- Bleeding on probing(12 months)
Investigators
Claudio Mendes Pannuti
Associate Professor
University of Sao Paulo