Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Periodontitis Clinical Trial

Official title:

Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030470
• Other study ID #: 5716
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: March 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
France	Service de parodontologie	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of periodontal pocket depth	Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month	6 months
Secondary	Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora		6 months