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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Comparison of conventional free gingival graft versus partial free gingival graft
Comparison of conventional free gingival graft versus partial free gingival graft
Sponsored by
Yonca Naziker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Partial de-epithelialized free gingival graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • İzmir Katip Çelebi University Faculty of dentistry, Periodontology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

control group(conventional free gingival graft)

test group(Partially de-epithelialized free gingival graft)

Arm Description

Conventional free gingival grafts are applied to the areas of the patients determined by randomization as suggested by Sullivan and Atkins.

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.

Outcomes

Primary Outcome Measures

aesthetic evaluation of both surgical methods
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 Outcome Measures

clinical parameters
In the clinical evaluation of both surgical methods, keratinized tissue width parameters were calculated and compared at baseline and pot-op 6 months.

Full Information

First Posted
April 8, 2021
Last Updated
September 12, 2021
Sponsor
Yonca Naziker
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1. Study Identification

Unique Protocol Identification Number
NCT04970524
Brief Title
Comparison of Conventional Free Gingival Grafts With Partially De-epithelized Free Gingival Grafts
Official Title
Aesthetic Evaluation of Free Gingival Graft Applied by Partial De-epithelialization and Free Gingival Graft Applied by Conventional Method: a Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yonca Naziker

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Partial de-epithelialized free gingival graft

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
control group(conventional free gingival graft)
Arm Type
Experimental
Arm Description
Conventional free gingival grafts are applied to the areas of the patients determined by randomization as suggested by Sullivan and Atkins.
Arm Title
test group(Partially de-epithelialized free gingival graft)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Comparison of conventional free gingival graft versus partial free gingival graft
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Comparison of conventional free gingival graft versus partial free gingival graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
aesthetic evaluation of both surgical methods
Description
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.
Time Frame
change in post-op 6 months
Secondary Outcome Measure Information:
Title
clinical parameters
Description
In the clinical evaluation of both surgical methods, keratinized tissue width parameters were calculated and compared at baseline and pot-op 6 months.
Time Frame
change in post-op 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
İzmir Katip Çelebi University Faculty of dentistry, Periodontology department
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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