Periodontitis
Conditions
Keywords
Periodontitis, treatment, photodynamic, mid-term, bacteria
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.
Interventions
OTHERFotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of periodontal pocket depth | 6 months | Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month |
Secondary
| Measure | Time frame |
|---|---|
| Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora | 6 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Luc Davideau, MDPHD
Les Hôpitaux Universitaires de Strasbourg
Outcome results
None listed