Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

April 5, 2011 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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)
Experimental: Light-emitting diode Irradiation
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
625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark
Experimental: applying photosensitizer
will be treated only by toluidine blue O
Other: applying Photosensitizer
toluidine blue O is applied at the bottom of each periodontal pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth
Time Frame: Baseline, one month, three month
distance from gingival margin to base of the clinical pocket by William's periodontal probe
Baseline, one month, three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment loss
Time Frame: 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
Baseline, one month, three month
Bleeding upon probing
Time Frame: Baseline, one month, three month
presence or the absence of bleeding up to 30 second after probing with a William's periodontal probe
Baseline, one month, three month
plaque index
Time Frame: 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
Baseline,before PDT procedure, one month, three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: Neda Moslemi, DDS,MS, Tehran University of Medical Sciences
  • Principal Investigator: Seyed Hossein Bassir, DDS, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09123209916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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