Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Study Overview
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Brief Summary
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Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for periodontal diseases display more or less pronounced persistence of periodontal tissue infection, inflammation, and destruction. The therapeutic additional value of photodynamic anti-infectious treatment remains controversial. The objective of this study is to evaluate the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment outcomes and to define its specific therapeutic indications.

Official Title
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Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Conditions
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Periodontitis

Intervention / Treatment
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* Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 40 years signed informed consent generalized severe chronic periodontitis patient with at least 24 teeth more than 30% of sites with clinical attachment loss >5mm- at least 5 sites with pocket depth >4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30% Exclusion Criteria: aggressive periodontitis smoking more than 10cig/day patient with endocarditis risk or need of antibiotic prophylaxis pregnant women patient included in other trials patient under guardianship patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels…) influencing periodontal status within 6 months before examination patient suffering from diseases influencing periodontal status (diabetes…) patient periodontally treated with root planing or periodontal surgery within 1 year before examination patient with scheduled extensive prosthetic treatment patient with a high haemorrhagic risk (INR>4) impossible patient cooperation

Ages Eligible for Study
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Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fotosan<br> | Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of periodontal pocket depth | Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, treatment, photodynamic, mid-term, bacteria