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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970524
• Other study ID #: 2020-TDU-DISF-0002
• Status: Completed
• Phase: N/A
• Start date: May 5, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: September 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 4, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Izmir Katip Çelebi University Faculty of dentistry, Periodontology department	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Yonca Naziker

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change in post-op 6 months
Secondary	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.	change in post-op 6 months