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

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Free Gingival Graft
Original Free Gingival Graft technique
Modified Free Gingival Graft technique
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Free gingival graft, keratinized gingival tissue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Faculdade de Odontologia da USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Free Gingival Graft

Original Free Gingival Graft technique

Arm 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.

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

Outcomes

Primary Outcome Measures

Apical-cervical width of keratinized tissue after 12 months
Distance between gingival margin and mucogingival junction, in millimeters

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2015
Last Updated
November 3, 2018
Sponsor
University of Sao Paulo
Collaborators
Universidade Estadual de Maringá
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1. Study Identification

Unique Protocol Identification Number
NCT02613702
Brief Title
Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Acronym
EFFECT
Official Title
Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Universidade Estadual de Maringá

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Free gingival graft, keratinized gingival tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Free Gingival Graft
Arm Type
Experimental
Arm 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.
Arm Title
Original Free Gingival Graft technique
Arm Type
Active Comparator
Arm Description
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Intervention Type
Procedure
Intervention Name(s)
Free Gingival Graft
Intervention Description
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
Intervention Type
Procedure
Intervention Name(s)
Original Free Gingival Graft technique
Intervention Description
Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area
Intervention Type
Procedure
Intervention Name(s)
Modified Free Gingival Graft technique
Intervention Description
Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area
Primary Outcome Measure Information:
Title
Apical-cervical width of keratinized tissue after 12 months
Description
Distance between gingival margin and mucogingival junction, in millimeters
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Probing Depth
Description
Distance between gingival margin and bottom of the sulcus / pocket, in millimeters
Time Frame
12 months
Title
Keratinized tissue area
Description
Keratinized tissue area, measured in millimeters
Time Frame
12 months
Title
Keratinized tissue thickness
Description
Keratinized tissue thickness measured in millimeters
Time Frame
12 months
Title
Volume of receiving area
Description
Volume of receiving area
Time Frame
12 months
Title
Complete epithelization of donor area
Description
Area of Epithelization of wound healing, measured in mm2
Time Frame
28 days
Title
Postoperative discomfort
Description
discomfort measured using Visual Analogue Scale
Time Frame
28 days
Title
Gum color
Description
Measured with photographic analysis
Time Frame
12 months
Title
Oral Health Related Quality of Life (OHIP)
Description
OHIp - 14 short version
Time Frame
12 months
Title
Clinical Attachment Level
Description
Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters
Time Frame
12 months
Title
Recession
Description
Distance between cementum-enamel junction and gingival margin, measured in millimeters
Time Frame
12 months
Title
Bleeding on probing
Description
percentage of sites which bled upon probing
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio M Pannuti, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
João Batista C Neto, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Odontologia da USP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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