Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain

August 6, 2012 updated by: saranaz azari-marhabi, Shahid Beheshti University

Phase 1 Study of Low Level Laser Therapy Versus Naproxen

tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

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

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1983969411
        • Not yet recruiting
        • Shahid Beheshti University
      • Tehran, Iran, Islamic Republic of, 1983969411
        • Recruiting
        • Shahid Beheshti University
        • Contact:
        • Principal Investigator:
          • saranaz azari-marhabi, resident

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

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with TMD affecting masticatory muscles

Exclusion Criteria:

  • systemic disease
  • GI problem
  • pregnancy
  • epidermal cancer

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low level laser therapy
this arm recieves low level laser therapy treatment for 12 sessions.
Radiation: low level laser therapy
Experimental: naproxen
this arm takes naproxen 500 mg twice daily for 3weeks
Drug: Naproxen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of paim measured by VAS
Time Frame: 1 month
VAS is visual analogue scale
1 month

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University

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

June 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

August 4, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-1233-RV

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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