Treatment Outcome of Supervised Exercise and Home Exercise in Patients with Symptomatic Disc Displacement with Reduction

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.

Study Overview

• Status: Completed
• Conditions: Anterior Disc Displacement
• Intervention / Treatment: Behavioral: Supervised Exercise Group; Behavioral: Home Exercise Group

Detailed Description

This study will help the clinical practitioner to choose better exercise option in patients with symptomatic disc displacement with reduction in order to avoid clicking sound.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Armed Forces Institute of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-70 years
2. Both genders

3. TMJ clicking sounds fulfilling RDC/TMD for symptomatic disc displacement

   1. Clicking sounds during jaw opening and closing
   2. Interincisor distance ≥ 5mm wider during mouth opening
   3. Clicking suppression with protruded mandible
   4. Clicking presence in at least two of three repetitions
4. NRS score ≥ 4 for TMJ clicking sound severity
5. TMJ clicking sound frequency: once a week or more

Exclusion Criteria:

1. Major psychiatric disorders
2. Ongoing treatments related to symptoms
3. Active rheumatologic disease
4. Malignant disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised Exercise Group; Patients receive supervised exercise therapy from a qualified physical therapist or healthcare professional, with a set frequency and duration	Behavioral: Supervised Exercise Group; 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.
Active Comparator: Home Exercise Group; Patients receive written instructions and demonstrations for performing exercises at home, with recommended frequency and duration	Behavioral: Home 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clicking sounds frequency	Assessment of clicking sounds frequency before and after intervention.	3 months

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Dentistry, Pakistan
• Investigators: Principal Investigator: Ayesha Younas, BDS, Armed Forces Institute of Dentistry, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): February 21, 2025
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AYounas

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No