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Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy

Primary Purpose

Periradicular Disease

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

diode laser

Methylene blue

About this trial

This is an interventional treatment trial for Periradicular Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- endodontic retreatment of teeth with periradicular lesion.

Exclusion Criteria:

Sites / Locations

Shahid Beheshti UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

in the second group diode laser (810 nm, 1.2 W, 30 s) was irradiated. Then second samples were taken from all canals.

In the first group Photodynamic therapy (PDT) with Methylene blue and diode laser (810 nm, 0.2 W, 40 second) was done

Outcomes

Primary Outcome Measures

bacterial colony forming unit(CFU/ML)

after doing protocol in each groups CFU /ml for different bacteria will be counted

Secondary Outcome Measures

Full Information

NCT ID

NCT02555488

First Posted

September 15, 2015

Last Updated

September 18, 2015

Sponsor

Shahid Beheshti University

1. Study Identification

Unique Protocol Identification Number

NCT02555488

Brief Title

Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy

Official Title

Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy in Reducing the Microbial Flora of the Canal While Root Retreatment in Patients With Periradicular Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.

Detailed Description

Conventional techniques of root canal treatments such as mechanical instrumentation and chemical debridement with antimicrobial irrigants, such as Sodium hypochlorite (NaOCl) and chlorhexidine and use of calcium hydroxide do not always suffice to predictably render root canals free of bacteria Using the high-power diode laser is a new approach of disinfection allowing access to the previously unavailable areas, such as the tubular network. This study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.

6. Conditions and Keywords

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

Periradicular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

in the second group diode laser (810 nm, 1.2 W, 30 s) was irradiated. Then second samples were taken from all canals.

Arm Title

Arm Type

Experimental

Arm Description

In the first group Photodynamic therapy (PDT) with Methylene blue and diode laser (810 nm, 0.2 W, 40 second) was done

Intervention Type

Device

Intervention Name(s)

diode laser

Intervention Description

MB and diode

Intervention Type

Device

Intervention Name(s)

diode laser

Intervention Description

diode laser

Intervention Type

Drug

Intervention Name(s)

Methylene blue

Intervention Description

Methylene blue and diode laser was used

Primary Outcome Measure Information:

Title

bacterial colony forming unit(CFU/ML)

Description

after doing protocol in each groups CFU /ml for different bacteria will be counted

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - endodontic retreatment of teeth with periradicular lesion. Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

saranaz azari-marhabi, DMD

Phone

09190129151

saranazazari@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

mohammad asnaashari, DMD

Phone

09190129151

mo_asna@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

saranaz azari-marhabi, DMD

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shahid Beheshti University

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mohammad asnaashari

Phone

09190129151

12. IPD Sharing Statement

Learn more about this trial

Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy

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