Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Phase 4

Completed

• Conditions: Periodontitis
• Interventions: Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

• Registration Number: NCT02030470
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Study Start: 2014-06
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fotosan	Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection	-

Primary Outcome Measures

Name	Time	Method
Change of periodontal pocket depth	6 months	Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month

Secondary Outcome Measures

Name	Time	Method
Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora	6 months

Trial Locations

Locations (1)

Service de parodontologie; 🇫🇷 Strasbourg, Alsace, France