NCT04456946

Brief Summary

In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the literature in terms of determining which treatment method is more effective by evaluating the changes in the needles muscles with the use of occlusal splints and LLL with USG and other parameters in certain periods, as well as evaluating which parameters are more effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

June 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 12, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

June 23, 2020

Last Update Submit

April 9, 2023

Conditions

Low Level Laser and Occlusal Splint

Keywords

Low Level LaserOcclusal SplintTemporomandibular Disfunction

Outcome Measures

Primary Outcomes (1)

  • Joint Pain Scale

    Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study

    2 years

Study Arms (2)

Group of Low Level Laser Therapy

EXPERIMENTAL
Device: Low Level Laser Therapy

Group of Occlusal Splint Treatment

EXPERIMENTAL
Device: Occlusal Splint Treatment

Interventions

Low Level Laser TherapyDEVICE

Low Level Laser Therapy

Group of Low Level Laser Therapy
Occlusal Splint TreatmentDEVICE

Occlusal Splint Treatment

Group of Occlusal Splint Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems
  • Patients with pain in the joint and chewing muscle area

You may not qualify if:

  • Syndromic patients
  • Patients under the age of 18
  • Patients with a history of orthognathic surgery
  • Pregnants
  • Antidepressant Users
  • Patients Using Removable Dentures
  • Patients who have had joint treatment in the past six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Dentistry Faculty

Istanbul, Fatih, 34200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Ahmet Faruk Erturk, Assistant Professor

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 7, 2020

Study Start

April 12, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Locations

TU(1)