Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

NCT01330082 | Unknown Phase 2 DMC

• 1 other identifier: 09123209916
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Photodynamic therapy; Light-emitting diode; toluidine blue; scaling and root planing

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth

  distance from gingival margin to base of the clinical pocket by William's periodontal probe

  Baseline, one month, three month

Secondary Outcomes (3)

• Clinical attachment loss

  Baseline, one month, three month

• Bleeding upon probing

  Baseline, one month, three month

• plaque index

  Baseline,before PDT procedure, one month, three month

Study Arms (3)

Photodynamic therapy

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)

Other: Adjunctive Photodynamic Therapy

Light-emitting diode Irradiation

EXPERIMENTAL

will be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark)

Other: Light-emitting diod Irradiation

applying photosensitizer

EXPERIMENTAL

will be treated only by toluidine blue O

Other: applying Photosensitizer

Interventions

Adjunctive Photodynamic Therapy OTHER

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)

Photodynamic therapy

Light-emitting diod Irradiation OTHER

625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark

Light-emitting diode Irradiation

applying Photosensitizer OTHER

toluidine blue O is applied at the bottom of each periodontal pocket

applying photosensitizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 141555583, Iran

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neda Moslemi, DDS,MS

  Tehran University of Medical Sciences

  STUDY CHAIR

• Seyed Hossein Bassir, DDS

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: May 1, 2011
• Last Updated: April 6, 2011

Record last verified: 2011-04

Locations

IR (1)