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Clinical Trials/NCT04970524
NCT04970524
Completed
Not Applicable

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

Yonca Naziker1 site in 1 country15 target enrollmentMay 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Yonca Naziker
Enrollment
15
Locations
1
Primary Endpoint
aesthetic evaluation of both surgical methods
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2019
End Date
February 4, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yonca Naziker
Responsible Party
Sponsor Investigator
Principal Investigator

Yonca Naziker

Principal investigator Yonca Naziker

Izmir Katip Celebi University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • clinical parameters(change in post-op 6 months)

Study Sites (1)

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