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

NCT ID: NCT04970524

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-05
• Study Completion Date: 2021-02-04

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comparison of conventional free gingival graft versus partial free gingival graft

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Comparison of conventional free gingival graft versus partial free gingival graft

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonca Naziker

OTHER

Sponsor Role: lead

Responsible Party

Yonca Naziker

Principal investigator Yonca Naziker

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

İzmir Katip Çelebi University Faculty of dentistry, Periodontology department

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Naziker Y, Ertugrul AS. Aesthetic evaluation of free gingival graft applied by partial de-epithelialization and free gingival graft applied by conventional method: a randomized controlled clinical study. Clin Oral Investig. 2023 Jul;27(7):4029-4038. doi: 10.1007/s00784-023-05029-8. Epub 2023 Apr 28.

Reference Type: DERIVED

PMID: 37118334 (View on PubMed)

Other Identifiers

2020-TDU-DİŞF-0002

Identifier Type: -

Identifier Source: org_study_id