Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of the application of a citric acid + tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the outcomes of treatment of Miller's class I or II recession defects by subepithelial connective tissue graft.

Detailed Description
-----------------
Adult patients showing Miller's class I or II recession defects requiring root coverage were recruited to participate in the study. All patients were submitted to non surgical periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene instruction in order to reduce/eliminate gingival inflammation. After that, patients were randomly allocated to three different treatment groups based on root conditioning: G0- no conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds. Allocation was defined by a software. Root coverage was performed by subepithelial connective tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12 months post-operatively by a blinded trained expertise different from operator and included: pocket depth, recession height, clinical attachment level, width of keratinized gingiva, sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment according to visual analogic scale (VAS).

Official Title
-----------------
Conditioning of Root Surfaces With Citric Acid and Tetracycline for Different Application Times Improves the Outcomes of Root Coverage by Subepithelial Connective Tissue Graft: a Randomized Clinical Trial.

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

Intervention / Treatment
-----------------
* Other: Root conditioning with citric acid+tetracycline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of Miller's class I or II recession extending 2-5 mm apical to CEJ requiring root coverage for the following reasons: esthetics, progression of recession or hypersensitivity. Exclusion Criteria: smokers; pregnants; routine use of anti-convulsants, anti-hypertensive or cyclosporine; uncontrolled systemic diseases (e.g.: diabetes mellitus); systemic conditions that requires antibiotic prophylaxis (e.g.: history of bacterial endocarditis; rheumatoid arthritis; prosthetic valves); antibiotics, steroidal or non-steroidal anti-inflammatory intake in the 6-month previous period.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: G0<br>Root decontamination performed by scaling and root planing followed by rinsing with saline solution during the treatment of recession defects by subepithelial connective tissue graft (SCTG). Control group. | |
| Active Comparator: G90<br>Root conditioning with citric acid+tetracycline solution (1:1) for 90 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG). | Other: Root conditioning with citric acid+tetracycline solution<br>* Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft<br>|
| Active Comparator: G180<br>Root conditioning with citric acid+tetracycline solution (1:1) for 180 seconds after scaling and root planing, followed by rinsing with saline solution for root decontamination during the treatment of recession defects by subepithelial connective tissue graft (SCTG). | Other: Root conditioning with citric acid+tetracycline solution<br>* Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of root coverage (%REC) | Percentage of root coverage obtained at 1 year after procedure. Represented by the difference of baseline recession height and final recession height divided by baseline recession height multiplied by 100 (in percentage). | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in recession height | Linear difference between final recession height and baseline recession height, measured by a millimeter periodontal probe as the distance from cementum-enamel junction and gingival margin at the center of recession defect (in mm). | one year | 
| increase in the width of keratinized gingiva | Linear difference between final and baseline width of keratinized gingiva. Measured with a millimeter periodontal problem as the distance from gingival margin to mucogingival junction (in mm). | one year | 
| gain in clinical attachment level | Linear difference between final and baseline clinical attachment level. Measured with a millimeter periodontal probe as the distance from cementum-enamel junction and the bottom of the sulcus or pocket (in mm). | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gingival recession, soft tissue, root biomodification, root coverage, citric acid, tetracycline