Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Tehran University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01330082
First received: April 4, 2011
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Chronic Periodontitis
Other: Adjunctive Photodynamic Therapy
Other: Light-emitting diod Irradiation
Other: applying Photosensitizer
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Probing pocket depth [ Time Frame: Baseline, one month, three month ] [ Designated as safety issue: No ]
    distance from gingival margin to base of the clinical pocket by William`s periodontal probe


Secondary Outcome Measures:
  • Clinical attachment loss [ Time Frame: Baseline, one month, three month ] [ Designated as safety issue: No ]
    distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites

  • Bleeding upon probing [ Time Frame: Baseline, one month, three month ] [ Designated as safety issue: No ]
    presence or the absence of bleeding up to 30 second after probing with a William`s periodontal probe

  • plaque index [ Time Frame: Baseline,before PDT procedure, one month, three month ] [ Designated as safety issue: No ]
    teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3


Enrollment: 16
Study Start Date: April 2010
Estimated Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330082

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 141555583
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01330082     History of Changes
Other Study ID Numbers: 09123209916
Study First Received: April 4, 2011
Last Updated: April 5, 2011
Health Authority: Iran: Tehran University of Medical Sciences

Keywords provided by Tehran University of Medical Sciences:
Photodynamic therapy
Light-emitting diode
toluidine blue
scaling and root planing

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Photosensitizing Agents
Tolonium Chloride
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Hemostatics
Coagulants
Hematologic Agents
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014