Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01330082
• Other study ID #: 09123209916
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: April 4, 2011
• Last updated: April 5, 2011
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Other:
• 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)
• Light-emitting diod Irradiation
625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark
• applying Photosensitizer
toluidine blue O is applied at the bottom of each periodontal pocket

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth	distance from gingival margin to base of the clinical pocket by William`s periodontal probe	Baseline, one month, three month
Secondary	Clinical attachment loss	distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites	Baseline, one month, three month
Secondary	Bleeding upon probing	presence or the absence of bleeding up to 30 second after probing with a William`s periodontal probe	Baseline, one month, three month
Secondary	plaque index	teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3	Baseline,before PDT procedure, one month, three month