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

May 20, 2025 updated by: Claudio Mendes Pannuti, University of Sao Paulo
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05508-000
        • Faculdade de Odontologia da USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Free Gingival Graft
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
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
Active Comparator: Original Free Gingival Graft technique
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Procedure: Free Gingival Graft
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apical-cervical width of keratinized tissue after 12 months
Time Frame: 12 months
Distance between gingival margin and mucogingival junction, in millimeters
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Universidade Estadual de Maringá

Investigators

  • Principal Investigator: Claudio M Pannuti, PhD, University of Sao Paulo
  • Study Director: João Batista C Neto, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimated)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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