Overview

This trial is active, not recruiting.

Condition chronic periodontitis
Treatments adjunctive photodynamic therapy, light-emitting diod irradiation, applying photosensitizer
Phase phase 2/phase 3
Sponsor Tehran University of Medical Sciences
Start date April 2010
End date November 2010
Trial size 16 participants
Trial identifier NCT01330082, 09123209916

Summary

The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
will be treated by PDT using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)
adjunctive photodynamic therapy
using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)
(Experimental)
will be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark)
light-emitting diod irradiation
625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark
(Experimental)
will be treated only by toluidine blue O
applying photosensitizer
toluidine blue O is applied at the bottom of each periodontal pocket

Primary Outcomes

Measure
Probing pocket depth
time frame: Baseline, one month, three month

Secondary Outcomes

Measure
Clinical attachment loss
time frame: Baseline, one month, three month
Bleeding upon probing
time frame: Baseline, one month, three month
plaque index
time frame: Baseline,before PDT procedure, one month, three month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. clinically diagnosis of advanced chronic periodontitis with more than 3 mm clinical attachment loss 2. presence of at least two teeth with probing depth of 4 to 6 mm without furcation involvement in each quadrant 3. at least 16 remaining teeth 4. no periodontal treatment in the past 12 months 5. no evidence of systemic disease related to periodontal problems 6. no use of antibiotics for the past 6 months 7. No smoking more than 10 cigarettes per day 8. no addiction to any kind of drugs 9. no pregnancy

Additional Information

Official title Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis
Principal investigator Seyed Hossein Bassir, DDS
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.