Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis.

Official Title
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Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Other: Adjunctive Photodynamic Therapy
* Other: Light-emitting diod Irradiation
* Other: applying Photosensitizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically diagnosis of advanced chronic periodontitis with more than 3 mm clinical attachment loss presence of at least two teeth with probing depth of 4 to 6 mm without furcation involvement in each quadrant at least 16 remaining teeth no periodontal treatment in the past 12 months no evidence of systemic disease related to periodontal problems no use of antibiotics for the past 6 months No smoking more than 10 cigarettes per day no addiction to any kind of drugs no pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photodynamic therapy<br>will be treated by PDT using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO) | Other: Adjunctive Photodynamic Therapy<br>* using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)<br>|
| Experimental: Light-emitting diode Irradiation<br>will be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) | Other: Light-emitting diod Irradiation<br>* 625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark<br>|
| Experimental: applying photosensitizer<br>will be treated only by toluidine blue O | Other: applying Photosensitizer<br>* toluidine blue O is applied at the bottom of each periodontal pocket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | distance from gingival margin to base of the clinical pocket by William's periodontal probe | Baseline, one month, three month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment loss | distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites | Baseline, one month, three month | 
| Bleeding upon probing | presence or the absence of bleeding up to 30 second after probing with a William's periodontal probe | Baseline, one month, three month | 
| plaque index | teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3 | Baseline,before PDT procedure, one month, three month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photodynamic therapy, Light-emitting diode, toluidine blue, scaling and root planing