Comparison of Conventional Free Gingival Grafts With Partially De-epithelized Free Gingival Grafts

September 12, 2021 updated by: Yonca Naziker

Aesthetic Evaluation of Free Gingival Graft Applied by Partial De-epithelialization and Free Gingival Graft Applied by Conventional Method: a Randomized Controlled Clinical Study

In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues.

This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method.Clinical parameters and aesthetic harmony were compared at postoperative 1st, 3rd and 6th months after surgical procedures.Color harmony evaluation was made in 2 different ways, both by photo analysis of a blind researcher using computer software and by visual evaluation of the same blind researcher.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this split mouth randomized controlled clinical trial is to compare the partial de-epithelialized free gingival grafting technique with the conventional free gingival grafting technique from an aesthetic point of view. The secondary aim of the study is to evaluate both techniques in terms of periodontal clinical parameters.

This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method. Fifteen patients with attached gingiva width ≤2 mm in the lower jaw bilateral canine and premolar regions were included in the study. De-epithelialized free gingival grafts were applied to the region determined by envelope randomization, and conventional free gingival grafts were applied to the other region. The areas of the patients with insufficient attached gingiva were photographed before the operation, post-op 1st, 3rd, and 6th months, and visual aesthetic evaluations were made with photo analyzes. Clinical parameters such as keratinized gingival width, probing pocket depth, and recession depths were recorded at baseline and at 6 months. Results were represented as mean ± standard deviation and median, and a p value of <0,05 was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

15

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

  • Turkey
      • Izmir, Turkey
        • İzmir Katip Çelebi University Faculty of dentistry, Periodontology department

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Absence of known systemic disease
  • Not using any medication that may affect the periodontal tissues or prolong the bleeding time
  • Having not previously operated on the palate area, which is both the receiving area and the donor area.
  • The depth of the probing sulcus of all teeth is <3 mm
  • Whole mouth plaque index and gingival index scores <1
  • The teeth in the operation area are vital
  • Absence of caries and / or restoration on the root surfaces of the teeth in the operation area
  • Lack of attached gingiva in opposite jaws

Exclusion Criteria:

  • Pregnant or lactating women,
  • Smoking individuals,
  • Individuals under the age of 18

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: control group(conventional free gingival graft)
Conventional free gingival grafts are applied to the areas of the patients determined by randomization as suggested by Sullivan and Atkins.
Procedure: Comparison of conventional free gingival graft versus partial free gingival graft

Conventional free gingival graft was applied to the area of the patient with attached gingival insufficiency determined by randomization.

Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.

Procedure: Comparison of conventional free gingival graft versus partial free gingival graft

Partially de-epithelialized free gingival graft was applied to the other region of the patient with attached gingival insufficiency determined by randomization.

Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.
Experimental: test group(Partially de-epithelialized free gingival graft)
Partial free gingival graft is applied to the areas of the patients determined by randomization. Unlike the control group, the epithelium on the graft was partially epithelialized.
Procedure: Comparison of conventional free gingival graft versus partial free gingival graft

Conventional free gingival graft was applied to the area of the patient with attached gingival insufficiency determined by randomization.

Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.

Procedure: Comparison of conventional free gingival graft versus partial free gingival graft

Partially de-epithelialized free gingival graft was applied to the other region of the patient with attached gingival insufficiency determined by randomization.

Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aesthetic evaluation of both surgical methods
Time Frame: change in post-op 6 months
Aesthetic evaluation of both surgical methods was done by a blinded researcher by photo analysis. For photo analysis, photographs of the recipient area were taken at the beginning and 6 months after the operation with the help of Adobe Photoshop program and evaluated on these photographs.
change in post-op 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical parameters
Time Frame: change in post-op 6 months
In the clinical evaluation of both surgical methods, keratinized tissue width parameters were calculated and compared at baseline and pot-op 6 months.
change in post-op 6 months

Collaborators and Investigators

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

Sponsor

Yonca Naziker

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)

May 5, 2019

Primary Completion (Actual)

September 15, 2020

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

July 10, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-TDU-DİŞF-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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