Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

Phase 2

• Conditions: Chronic Periodontitis
• Interventions: Other: Adjunctive Photodynamic Therapy; Other: Light-emitting diod Irradiation; Other: applying Photosensitizer

• Registration Number: NCT01330082
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-11
• Status Verified: 2011-04
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Last Update Submitted: 2011-04-05
• Study First Posted: 2011-04-06
• Last Update Posted: 2011-04-06
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Photodynamic therapy	Adjunctive Photodynamic Therapy	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)
Light-emitting diode Irradiation	Light-emitting diod Irradiation	will be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark)
applying photosensitizer	applying Photosensitizer	will be treated only by toluidine blue O

Primary Outcome Measures

Name	Time	Method
Probing pocket depth	Baseline, one month, three month	distance from gingival margin to base of the clinical pocket by William's periodontal probe

Secondary Outcome Measures

Name	Time	Method
Clinical attachment loss	Baseline, one month, three month	distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites
Bleeding upon probing	Baseline, one month, three month	presence or the absence of bleeding up to 30 second after probing with a William's periodontal probe
plaque index	Baseline,before PDT procedure, one month, three month	teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of