NCT07588841

Brief Summary

This clinical study aimed to evaluate the effectiveness of low-level laser therapy in patients with temporomandibular disorders (TMD), specifically disc displacement with reduction and myalgia. The study compared laser therapy with a soft diet approach to determine whether laser treatment provides additional benefits in reducing pain and improving jaw function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

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

September 3, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

May 7, 2026

Last Update Submit

May 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in temporomandibular pain intensity measured by the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up

    Change in temporomandibular pain intensity was assessed using the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up. The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain severity.

    6 month

Study Arms (2)

Low Level Laser Therapy

ACTIVE COMPARATOR

Participants in this group received low-level laser therapy applied to the temporomandibular joint region according to the predefined treatment protocol. Laser therapy was administered for 2 minutes per joint over 9 treatment sessions. Patients were also advised to follow a soft diet during the treatment period.

Other: Low Level Laser Therapy

soft diet group

OTHER

Soft Diet Group: Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes.

Other: Dietary Supplement

Interventions

Participants received low-level laser therapy applied to the temporomandibular joint region in addition to soft diet recommendations. Treatment was performed in 9 sessions according to the predefined laser protocol. Participants followed a soft diet regimen without receiving laser therapy and served as the comparison group.

Low Level Laser Therapy

Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes.

soft diet group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of disc displacement with reduction (DDwR) and myalgia according to DC/TMD criteria Presence of temporomandibular joint pain and functional limitation Patients aged 18 years and older No previous temporomandibular joint (TMJ) treatment Absence of systemic diseases Willingness to participate and provide informed consent

You may not qualify if:

  • History of previous TMJ treatment (e.g., conservative or surgical treatment) Congenital or inflammatory joint disease Severe systemic diseases Edentulous patients Children and adolescents in the active growth period Acute trauma history involving the TMJ region Inability or unwillingness to complete follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Trabzon, 61000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light TherapyDietary Supplements

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of two parallel groups: a low-level laser therapy group or a soft diet group. Outcomes were assessed at baseline, after completion of treatment sessions, and during follow-up evaluations.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 15, 2026

Study Start

September 3, 2022

Primary Completion

December 24, 2024

Study Completion

December 24, 2024

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality considerations related to patient data

Locations