The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.

Detailed Description
-----------------
Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.

Official Title
-----------------
The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial

Conditions
-----------------
Gingival Recession, Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: Root coverage treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic healthy individuals Presence Miller's class I and II gingival recession in the anterior and premolar teeth Exclusion Criteria: Age <18 years Pregnancy Lactation Any cardiovascular, renal or hepatic conditions History of periodontal surgery Tooth mobility Presence of probing depth >3 mm and caries or restorations in the teeth undergoing treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gingival Unit Graft<br>For test group, gingival recessions were treated with gingival unit graft. | Procedure: Root coverage treatment<br>* Gingival unit graft Connective tissue graft<br>|
| Other: Connective Tissue Graft<br>For Control group, gingival recessions were treated with connective tissue graft. | Procedure: Root coverage treatment<br>* Gingival unit graft Connective tissue graft<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Gingival Recession Depth at 6 month | The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score) | Baseline and month 6. | 
| Change from Baseline Keratinized Gingiva Height at 6 month | Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score) | Baseline and month 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Root Hypersensitivity at 6 month | Root hypersensitivity at baseline and post-operative 6 month utilizing a visual numerical scale (VNS) test are defined. Possible scores range from (0=no sensitive and 10= worst possible sensitive). Change= (6 month score-baseline score) | Baseline and month 6. | 
| Change from Baseline Patient Satisfaction at 6 month | The patient satisfaction with the gingiva position, structure and color of the gingival recessions sites utilizing a VNS test (0=not satisfied and 10=very satisfied) are defined. Possible scores range from 0 (not satisfied) to 10 (very satisfied). Change= (6 month score-baseline score) | Baseline and month 6. | 
| Change from Baseline Pain at 1 week | Pain perception of the surgery at intra and post-operative period (week 1) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (1 week score-baseline score) | Baseline and week 1. | 
| Change from Baseline Pain at 2 week | Pain perception of the surgery at intra and post-operative period (week 2) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (2 week score-baseline score) | Baseline and week 2. |