- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575100
Maitland Mobilization Versus Therapeutic Ultrasound on Trismus Following Third Molar Surgery
Effect of Maitland Mobilization Versus Therapeutic Ultrasound on Trismus Following Third Molar Surgery
This study aims to compare the effect of Maitland mobilization and therapeutic ultrasound on trismus (limited mouth opening) following third molar (wisdom tooth) surgery.
Participants who experience limited mouth opening after third molar surgery will receive one of two treatment methods: Maitland joint mobilization or therapeutic ultrasound. These treatments are commonly used in physical therapy to improve jaw movement and reduce stiffness.
The purpose of this study is to determine which treatment is more effective in improving mouth opening and reducing symptoms after surgery.
Participation is voluntary, and all collected information will be kept confidential and used only for research purposes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical study will investigate the effect of Maitland mobilization compared to therapeutic ultrasound on trismus following third molar (wisdom tooth) surgery.
Trismus, characterized by limited mouth opening, is a common postoperative complication after third molar extraction and can affect oral function and quality of life All patients of both groups received Standard Postoperative Care designed to promote natural recovery after third molar surgery. The standard care protocol includes the use of Cold Compresses/Ice Packs, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), basic jaw exercises at home to prevent further restriction of jaw movement.
Group A Maitland Mobilization group: Participants received Maitland mobilization therapy. The manual therapy involved graded oscillatory movements targeting the temporomandibular joint (TMJ), aimed at improving jaw mobility and reducing pain following third molar surgery. Each therapy session lasted approximately 15-20 minutes and was conducted three times a week over a period of four weeks. During each session, the physiotherapist applied different grades of mobilization depending on the patient's progress. Grade I and II movements-small, rhythmic oscillations-were used initially to reduce pain and relax the muscles. As the treatment progressed, Grade III and IV mobilizations were applied to stretch the joint capsule and further improve range of motion. Additionally, patients were instructed to perform home exercises to maintain the therapeutic gains between sessions, such as gentle jaw stretching and mouth-opening exercises .
Group B (Therapeutic Ultrasound group): The procedure involved using an ultrasound device , such as the Chattanooga Intelect Mobile 2, which operates at a 1 MHz frequency to target deep tissues like the temporomandibular joint (TMJ) and surrounding muscles. The therapy was conducted three times a week for four weeks, with each session lasting 10-15 minutes. A water-based conductive gel was applied to the skin to facilitate effective transmission of sound waves, and the intensity of the ultrasound was adjusted between 0.8 to 1.5 W/cm² based on patient tolerance. The transducer was moved in slow, circular motions over the TMJ and affected muscles, focusing on areas of pain or stiffness. Group C (Control group ): received traditional physical therapy program only. The outcomes measured included Maximum Interincisal Opening (MIO) via a Vernier Caliper. MIO was measured as the primary indicator of jaw mobility in patients experiencing postoperative trismus. MIO is the distance between the upper and lower central incisors when the patient opens their mouth fully, with the patient seated comfortably and properly supported. The MIO was recorded at baseline (before the intervention) and again at the end of the 4-week intervention period. Each measurement was repeated three times to ensure accuracy, with the average of the three readings used as the final recorded value. This process allows for consistent and precise tracking of improvements in jaw mobility over time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
El-Sharqia Governorate
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Abū Ḩammād, El-Sharqia Governorate, Egypt
- Abu Hammad General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients were included in this study have the following criteria
- Sixty patients had done third molar extraction surgery
- Patients suffering from postoperative trismus within 2 to 14 days post-surgery.
- Their age between 20 and 30 years old
- All patients are medically and clinically stable when attending the study 2.1.2. Exclusion criteria:
The study excluded the following patients:
- Pre-existing TMJ Disorders: Patients with a history of temporomandibular joint (TMJ) disorders or jaw-related conditions (e.g., TMJ dislocation, arthritis, or previous TMJ surgery).
- Neurological or Muscular Disorders: (e.g., facial palsy, stroke, muscular dystrophy).
- Previous Jaw Surgery or Trauma.
- Use of Muscle Relaxants or other form of Physical Therapy treatment.
- Chronic Pain Syndromes: such as fibromyalgia or chronic migraines
- Infections or abscesses post-Surgery.
- Patients have auditory and visual problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Maitland Mobilization Group
Participants in this group received Maitland mobilization techniques applied to the temporomandibular joint.
The intervention was performed by a trained therapist using graded passive mobilization techniques aimed at improving joint mobility and reducing trismus.
Treatment sessions were conducted over the study period with standardized frequency and duration
|
Maitland mobilization was applied to the temporomandibular joint using graded passive accessory and physiological joint mobilization techniques (Grade I-IV depending on patient tolerance).
The technique was performed by a trained physical therapist to improve joint mobility and reduce trismus following third molar surgery.
Treatment sessions were conducted three times per week for four weeks
|
|
Experimental: Therapeutic Ultrasound group
Participants received therapeutic ultrasound applied to the temporomandibular joint and surrounding muscles.
The ultrasound was delivered at a frequency of 1 MHz to target deep tissues.
Treatment sessions were conducted three times per week for four weeks, with each session lasting 10-15 minutes.
A water-based conductive gel was applied to enhance transmission of sound waves.
The intensity ranged from 0.8 to 1.5 W/cm² based on patient tolerance, and the transducer was moved in slow circular motions over the affected area to reduce pain and stiffness
|
using an ultrasound device , such as the Chattanooga Intelect Mobile 2, which operates at a 1 MHz frequency to target deep tissues like the temporomandibular joint (TMJ) and surrounding muscles.
The therapy was conducted three times a week for four weeks, with each session lasting 10-15 minutes.
A water-based conductive gel was applied to the skin to facilitate effective transmission of sound waves, and the intensity of the ultrasound was adjusted between 0.8 to 1.5 W/cm² based on patient tolerance.
The transducer was moved in slow, circular motions over the TMJ and affected muscles, focusing on areas of pain or stiffness (Bhushan et al., 2025).
|
|
Active Comparator: Control group
traditional physical therapy program (Standard Postoperative Care, Cold Compresses/Ice Packs, NSAIDs);
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the traditional physical therapy program (Standard Postoperative Care, Cold Compresses/Ice acks, NSAIDs);
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity level
Time Frame: Baseline, immediately post-intervention
|
Pain intensity level via The Visual Analog Scale (VAS): The VAS is self-completed by the participant. The participant is asked to place a line perpendicular to the VAS 100 mm line at the point that represents their pain intensity. The examiner reported the VAS score by measuring the distance (mm) from the marked point to the "no pain" anchor using a ruler, providing a range of scores from 0 -100 (Boonstra et al., 2008) |
Baseline, immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Interincisal Opening
Time Frame: Baseline, immediately post-intervention
|
Maximum Interincisal Opening (MIO) via a digital caliper: The maximum interincisal opening (MIO) measured as the primary indicator of jaw mobility in patients experiencing postoperative trismus. MIO is the distance between the upper and lower central incisors when the patient opens their mouth fully. The measurement taken using a digital caliper, with the patient seated comfortably and properly supported. The MIO will be recorded at baseline (before the intervention) and again at the end of the 4-week intervention period. Each measurement repeated three times to ensure accuracy, with the average of the three readings used as the final recorded value. This process allow for consistent and precise tracking of improvements in jaw mobility over time (Buesa-Bárez et al., 2018). |
Baseline, immediately post-intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000000 (MRDC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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