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Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Adjunctive Photodynamic Therapy

Light-emitting diod Irradiation

applying Photosensitizer

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Photodynamic therapy, Light-emitting diode, toluidine blue, scaling and root planing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Photodynamic therapy

Light-emitting diode Irradiation

applying photosensitizer

Arm Description

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)

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

will be treated only by toluidine blue O

Outcomes

Primary Outcome Measures

Probing pocket depth

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

Secondary Outcome Measures

Clinical attachment loss

distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites

Bleeding upon probing

presence or the absence of bleeding up to 30 second after probing with a William's periodontal probe

plaque index

teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3

Full Information

NCT ID

NCT01330082

First Posted

April 4, 2011

Last Updated

April 5, 2011

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01330082

Brief Title

Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Photodynamic therapy

Arm Type

Experimental

Arm Description

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)

Arm Title

Light-emitting diode Irradiation

Arm Type

Experimental

Arm Description

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

Arm Title

applying photosensitizer

Arm Type

Experimental

Arm Description

will be treated only by toluidine blue O

Intervention Type

Other

Intervention Name(s)

Adjunctive Photodynamic Therapy

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Light-emitting diod Irradiation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

applying Photosensitizer

Intervention Description

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

Primary Outcome Measure Information:

Title

Probing pocket depth

Description

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

Time Frame

Baseline, one month, three month

Secondary Outcome Measure Information:

Title

Clinical attachment loss

Description

distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites

Time Frame

Baseline, one month, three month

Title

Bleeding upon probing

Description

presence or the absence of bleeding up to 30 second after probing with a William's periodontal probe

Time Frame

Baseline, one month, three month

Title

plaque index

Description

teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3

Time Frame

Baseline,before PDT procedure, one month, three month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neda Moslemi, DDS,MS

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Seyed Hossein Bassir, DDS

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tehran University of Medical Sciences

City

Tehran

ZIP/Postal Code

141555583

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis

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