Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

University Hospital, Strasbourg, France

Status and phase

Completed

Phase 4

Conditions

Periodontitis

Treatments

Other: Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection

Study type

Interventional

Funder types

Other

Identifiers

NCT02030470

5716

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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