Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the additional effect of antimicrobial photodynamic therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone and porcine collagen membrane.

Official Title
-----------------
Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions

Conditions
-----------------
Periodontitis, Chronic, Periodontal Diseases, Periodontal Bone Loss

Intervention / Treatment
-----------------
* Procedure: Scaling and root planing
* Drug: Toluidine Blue O


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars Mandibular 1st and 2nd molars without caries, erosion or abrasion Exclusion Criteria: Smoking habit Pregnancy Use of antibiotics in the last six months Periodontal treatment in the last six months Endodontic lesion Systemic diseases that impair wound healing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Split-mouth design. One side of mouth is test and the other is control side.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Decontamination of furcation defect with scaling and root planing only. | Procedure: Scaling and root planing<br>* Furcation treatment by scaling and root planing<br>|
| Experimental: Antimicrobial Photodynamic Therapy<br>Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy. | Procedure: Scaling and root planing<br>* Furcation treatment by scaling and root planing<br>Drug: Toluidine Blue O<br>* Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.<br>* Other names: Antimicrobial photodynamic therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal probing depth | Measured with a periodontal probe (mm). Ideal if 0. | one year | 
| Tomographic Bone filling | Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm. | one year | 
| Clinical Attachment Level | Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm. | one year | 
| Bleeding on probing | Visual confirmation of bleeding after probing. Ideal if not bleeding. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal Guided Tissue Regeneration, Photochemotherapy