Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.

Detailed Description
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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. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.

Official Title
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Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.

Conditions
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Gingival Recession, Generalized, Gingival Recession

Intervention / Treatment
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* Procedure: Control
* Procedure: antimicrobial photodynamic therapy
* Procedure: Photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height) Indication of root coverage by dentin hypersensitivity or esthetic. Minimum palate thickness (1,5mm) Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%; Exclusion Criteria: Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids) Smokers Pregnancy Diabetics History of head and neck radiotherapy Teeth with mobility Malpositioned teeth History of periodontal surgery at the area on the last 12 months Patients with orthodontic therapy in progression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Root surface treatment by scaling and root planing | Procedure: Control<br>* In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.<br>* Other names: Scaling and root planing only;|
| Experimental: antimicrobial photodynamic therapy<br>Root surface treatment by antimicrobial photodynamic therapy | Procedure: antimicrobial photodynamic therapy<br>* In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)<br>|
| Active Comparator: Photobiomodulation<br>Treatment of the whole surgical site with laser | Procedure: Photobiomodulation<br>* After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.<br>* Other names: Low level laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total root coverage | Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized mucosa width | Keratinized mucosa width is measured with a periodontal probe in mm, from gingival margin to mucogingival junction. Ideal if keratinized mucosa width > 5mm | One year | 
| Probing depth | Probing depth measured with a periodontal probe in millimeters. The distance from gingival margin and the apical point of gingival pocket or sulcus. Ideal if <2mm. | One year | 
| Clinical attachment level | Clinical attachment level measured with a periodontal probe in millimeters. The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus. Ideal if <2mm. | One year | 
| Dentin hypersensitivity | Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale. Ideal if = 0. | One year |