NCT04257903

Brief Summary

Myofascial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The low-level laser therapy (LLLT) and occlusal splint therapy (OST) are therapeutic options for MPDS. This study aims to evaluate the effect of LLLT and OST on pain relief and mandibular movement improvement in patients with myofascial pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

January 28, 2020

Last Update Submit

February 5, 2020

Conditions

Keywords

Myofacial PainOcclusal SplintLow-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Visual Analogue Scale

    Pain intensity during muscle palpations. Scores are ranging from 0 to 10. Higher scores mean a worse outcome.

    Baseline, one month after the beginning of treatment and two months after the beginning of treatment

Secondary Outcomes (1)

  • Change from Baseline maximum unassisted mouth opening

    Baseline, one month after the beginning of treatment and two months after the beginning of treatment

Study Arms (2)

Occlusal Splint Therapy

The data of patients who previously received occlusal splint therapy were evaluated. Participants in the study received occlusal splint therapy, but the investigator did not assign this intervention specifically to the study participants. Participants received occlusal splint therapy as part of routine medical care, and a researcher studied the effect of occlusal splint therapy.

Low-Level Laser Therapy

The data of patients who previously received Low-Level Laser Therapy were evaluated. Participants in the study received Low-Level Laser Therapy, but the investigator did not assign this intervention specifically to the study participants. Participants received Low-Level Laser Therapy as part of routine medical care, and a researcher studied the effect of Low-Level Laser Therapy.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Thracian region

You may qualify if:

  • Diagnosis of myofascial pain syndrome according to The Research Diagnostic Criteria for Temporomandibular Disorder.
  • Individuals between the ages of 18-60
  • Occlusion of individuals with posterior teeth
  • Forms of individuals who do not have any systemic disease

You may not qualify if:

  • Disc displacement with or without reduction, with or without limited mouth opening, arthralgia, arthritis, arthrosis
  • Inflammatory connective tissue disease (such as rheumatoid arthritis)
  • Psychiatric diseases
  • Tumor
  • Heart diseases
  • Pregnancy
  • Diseases that may cause pain symptoms in other orofacial regions (toothache, neuralgia, migraine)
  • Having received any treatment for headache or bruxism in the last 2 years
  • Skin infections on the masseter and temporal muscles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Merkez, Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2020

First Posted

February 6, 2020

Study Start

April 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations