Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.

Detailed Description
-----------------
Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers. Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.

Official Title
-----------------
Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial

Conditions
-----------------
Gingival Recession

Intervention / Treatment
-----------------
* Procedure: Control
* Procedure: citric acid plus tetracycline
* Procedure: antimicrobial photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth Indication of root coverage by dentin hypersensitivity or esthetic Exclusion Criteria: Smokers Pregnancy Systemic medication use that could impair wound healing or surgery procedure Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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
Interventional Model Description: Interventions in different patients
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Root treatment with scaling and root planing. | Procedure: Control<br>* Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing<br>|
| Experimental: Citric acid plus tetracycline<br>Root treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s. | Procedure: citric acid plus tetracycline<br>* Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline<br>|
| Experimental: Antimicrobial photodynamic therapy<br>Antimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s) | Procedure: antimicrobial photodynamic therapy<br>* Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total root coverage measured with a periodontal probe in mm | Distance from cemento-enamel junction to gingival margin = 0 mm | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized mucosa width measured with a periodontal probe in mm | Ideal if keratinized mucosa width > 5mm | one year | 
| Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale | Ideal if scale = 0 | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gingival recession