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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Free Gingival Graft

Intervention Type PROCEDURE

Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.

Modified Free Gingival Graft technique

Intervention Type PROCEDURE

Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area

Original Free Gingival Graft technique

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

Group Type ACTIVE_COMPARATOR

Free Gingival Graft

Intervention Type PROCEDURE

Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.

Original Free Gingival Graft technique

Intervention Type PROCEDURE

Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area

Interventions

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Free Gingival Graft

Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes