Clinical trial NCT04970524: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Partial de-epithelialized free gingival graft
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: aesthetic evaluation of both surgical methods
timeFrame: change in post-op 6 months
Secondary outcomes:
measure: clinical parameters
timeFrame: change in post-op 6 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: İzmir Katip Çelebi University Faculty of dentistry, Periodontology department
Study officials:
References: