NCT01659372

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

August 4, 2012

Last Update Submit

August 6, 2012

Conditions

TMD

Keywords

temporomandibular disordermyofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

  • reduction of paim measured by VAS

    VAS is visual analogue scale

    1 month

Study Arms (2)

Low level laser therapy

EXPERIMENTAL

this arm recieves low level laser therapy treatment for 12 sessions.

Radiation: low level laser therapy

naproxen

EXPERIMENTAL

this arm takes naproxen 500 mg twice daily for 3weeks

Drug: Naproxen

Interventions

low level laser therapyRADIATION
Low level laser therapy
NaproxenDRUG
naproxen

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with TMD affecting masticatory muscles

You may not qualify if:

  • systemic disease
  • GI problem
  • pregnancy
  • epidermal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shahid Beheshti University

Tehran, 1983969411, Iran

NOT YET RECRUITING

Shahid Beheshti University

Tehran, 1983969411, Iran

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint DisordersMyofascial Pain Syndromes

Interventions

Low-Level Light TherapyNaproxen

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Central Study Contacts

saranaz azari marhabi, post graduate student

CONTACT

00989190129151saranazazari@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oral medicine resident

Study Record Dates

First Submitted

August 4, 2012

First Posted

August 7, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

IR(2)