NCT06534619

Brief Summary

Without appropriate early intervention, prolonged trismus can lead to lasting complications like reduced jaw mobility or temporomandibular joint disorders.Therefore joint mobilization will impact on trismus, that will offer valuable insights into how these interventions will affect inflammation, muscle function and overall healing process within TMJ besides rocabado exercises that involves a series of movements and stretches targeting the muscles and joints involved in chewing,swallowing and speaking and minimizing muscle tension and opening the mouth, preventing further deterioration of jaw function and improving overall quality of life of individuals. If found effective, this will be added to the literature for the treatment of trismus after third molar extraction.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    pain will be measured using Numeric pain rating scale

    1 week

  • Range of motion

    A Vernier caliper will be used to measure maximal incisal opening (MIO) ≤ 35 mm (ROM)

    1 week

  • Functional Performance

    Gothenburg Trismus Questionnaire will be used for assessing functional performance or trismus-related quality of life.

    1 week

Study Arms (2)

Maitland joint mobilization + Rocabdo exercises

EXPERIMENTAL

Therapeutic ultrasound: pulse mode - 1:4, frequency 3 MHz, intensity- 0.8 watt/cm2 for about 3-4 Minutes. Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3. Techniques used are anterior, lateral and inferior glides Frequency: 3-4 times in 1 week . 4 sessions in total.

Procedure: ElectrotherapyProcedure: Rocabado exercisesProcedure: Maitland oscillatory mobilizations

Rocabado exercises

EXPERIMENTAL

Participants of this Group will receive the conventional physical therapy along with 6 Rocabado exercises.6 reps each Therapeutic ultrasound: pulse mode - 1:4, frequency 3 MHz, intensity- 0.8 watt/cm2 for about 3-4 Minutes. Frequency: 3-4 times in 1 week . 4 sessions in total.

Procedure: ElectrotherapyProcedure: Rocabado exercises

Interventions

Therapeutic ultrasound: pulse mode - 1:4, frequency 3 MHz, intensity- 0.8 watt/cm2 for about 3-4 minutes.

Maitland joint mobilization + Rocabdo exercisesRocabado exercises

6 Rocabado exercises 6 Reps each.

Maitland joint mobilization + Rocabdo exercisesRocabado exercises

Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3. Techniques used are anterior, lateral and inferior glides

Maitland joint mobilization + Rocabdo exercises

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Referral or consultation from a dentist to confirm the diagnosis of trismus.
  • Age 18-45 years
  • Both genders (Male and Female)
  • Maximal interincisal opening ≤ 35mm (Restricted jaw motion).
  • Unilateral/Bilateral impacted lower third molars.
  • days Post mandibular Third molar extraction

You may not qualify if:

  • Local Infection or bleeding post third molar extraction.
  • Patients with Acute pericoronitis
  • Patient undergoing chemotherapy and radiotherapy.
  • Type I diabetes, renal failure and chronic liver disease were excluded as immunocompromised state.
  • Pregnant or lactating women.
  • Cyst or tumor associated with impacted tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Trismus

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trail, having two groups. One group will receive Maitland joint mobilization along with rocabado exercises and the second will receive rocabado exercises only. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

June 10, 2024

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations