Comparison Between Two Coronally Positioned Flap With Connective Tissue

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at Universidad El Bosque dental school clinics.

Detailed Description
-----------------
This is a blind, randomized controlled clinical trial.

Official Title
-----------------
Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial

Conditions
-----------------
Gingival Recession, Periodontal Atrophy

Intervention / Treatment
-----------------
* Procedure: coronally partial thickness flap plus connective tissue
* Procedure: coronally mucosal thickness flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Class I and II Miller recessions showing a recession depth ≥ 2 mm. Recessions isolated and / or maximum continuous two teeth. Recessions in incisors, canines and premolars Patients 20 to 60 years old. Exclusion Criteria: Systemic compromise, that contraindicates any periodontal surgical procedure. Warfarin medication. Uncontrolled diabetes mellitus with glycosylated hemoglobin ≥ 8 Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days) HIV-AIDS infection with CD4 counts <200. Immunosuppression. Recessions molars not be taken into account in the study. Patients who have used antibiotics one month prior to the surgical procedure. Pregnancy. Active smoker. Patients with a history of periodontal surgery at the recession area that has taken place in the last three months. Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery. Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ). Active inflammation that contraindicates surgical procedure of the recession. Active Orthodontics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: coronally mucosal thickness flap<br>coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft) | Procedure: coronally mucosal thickness flap<br>* The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.<br>* Other names: superficial-layer split-tihickness flap;|
| Active Comparator: coronally partial thickness flap<br>coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft) | Procedure: coronally partial thickness flap plus connective tissue<br>* The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.<br>* Other names: coronally positioned flap;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of Universidad El Bosque |  | one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the proportion of root coverage |  | one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days) | 
| Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures |  | one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronally positioned flap, connective tissue, gingival margin, gingival recession/ treatment, gingival recession/ surgery, subepithelial connective tissue graft, randomized controlled clinical trial, surgical flaps, Treatment outcome