NCT06651814

Brief Summary

The aim of the study is to evaluate the treatment outcome of supervised exercise and home exercise in patients with symptomatic disc displacement with reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 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

August 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

October 17, 2024

Last Update Submit

March 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • clicking sounds frequency

    Assessment of clicking sounds frequency before and after intervention.

    3 months

Study Arms (2)

Supervised Exercise Group

EXPERIMENTAL

Patients receive supervised exercise therapy from a qualified physical therapist or healthcare professional, with a set frequency and duration

Behavioral: Supervised Exercise Group

Home Exercise Group

ACTIVE COMPARATOR

Patients receive written instructions and demonstrations for performing exercises at home, with recommended frequency and duration

Behavioral: Home Exercise Group

Interventions

A supervised exercise program will consists of 10 sessions. The 1st exercise station will be a 5-minute warming up of the jaw with a heat lamp. The 2nd station will involve jaw opening-closing movements (TMJ rotation) with the mandible in a slightly protruded position for 6 minutes. The 3rd and 4th exercise stations will comprised of jaw opening and jaw protrusion, respectively, against resistance for 4 minutes each. Measurements will be done before the trial started and after 3 months.

Supervised Exercise Group

Patients will received a home regime of jaw exercises. They will be instructed to do two different trainings. The 1st type of exercise will be jaw opening and closing movements daily for 5 minutes after each meal with the mandible and the head of the TMJ in a slightly protruded position. This exercise should not produce any clicking sounds. The 2nd type of exercise will be isometric exercises; this entailed jaw opening and jaw protrusion against resistance with their hand for 10 seconds with 10 repetitions each daily. All the patients will receive a training brochure with photos of the exercises and detailed information on frequency and exercise time. The brochure will include a diary. After 6 weeks, the subject and the assistant will check the performance of the exercise and the diary

Home Exercise Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-70 years
  • Both genders
  • TMJ clicking sounds fulfilling RDC/TMD for symptomatic disc displacement
  • Clicking sounds during jaw opening and closing
  • Interincisor distance ≥ 5mm wider during mouth opening
  • Clicking suppression with protruded mandible
  • Clicking presence in at least two of three repetitions
  • NRS score ≥ 4 for TMJ clicking sound severity
  • TMJ clicking sound frequency: once a week or more

You may not qualify if:

  • Major psychiatric disorders
  • Ongoing treatments related to symptoms
  • Active rheumatologic disease
  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

  • Ayesha Younas, BDS

    Armed Forces Institute of Dentistry, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 22, 2024

Study Start

August 20, 2024

Primary Completion

February 21, 2025

Study Completion

February 21, 2025

Last Updated

March 4, 2025

Record last verified: 2025-03

Locations