Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-03-31

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.

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Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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fotosan

Group Type OTHER

Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

Intervention Type OTHER

Interventions

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Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

Intervention Type OTHER

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No