TrismusNCT06534619
Additional Effects of Joint Mobilization in Addition to Rocabado Exercises on Alleviating Trismus Following Third Molar Extraction
A study testing Electrotherapy, Rocabado exercises and Maitland oscillatory mobilizations in people with Trismus, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Trismus
- What is being tested?
- Electrotherapy, Rocabado exercises and Maitland oscillatory mobilizations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 3 days Post mandibular Third molar extraction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
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.
- Conditions
- Trismus
- Being tested
- Electrotherapy, Rocabado exercises, Maitland oscillatory mobilizations
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrotherapyProcedure or surgery
Therapeutic ultrasound: pulse mode - 1:4, frequency 3 MHz, intensity- 0.8 watt/cm2 for about 3-4 minutes.
Rocabado exercisesProcedure or surgery
6 Rocabado exercises 6 Reps each.
Maitland oscillatory mobilizationsProcedure or surgery
Mobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3.
Techniques used are anterior, lateral and inferior glides
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Electrotherapy; Procedure: Rocabado exercises; Procedure: 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. Receives: Procedure: Electrotherapy; Procedure: Rocabado exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
pain will be measured using Numeric pain rating scale
Measured: 1 week
Range of motion
A Vernier caliper will be used to measure maximal incisal opening (MIO) ≤ 35 mm (ROM)
Measured: 1 week
Functional Performance
Gothenburg Trismus Questionnaire will be used for assessing functional performance or trismus-related quality of life.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start10 Jun 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534619
- Sponsor's protocol ID
- FUI/CTR/2024/18
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Joint Mobilization in Addition to Rocabado Exercises on Alleviating Trismus Following Third Molar Extraction
- ClinicalTrials.gov ID
- NCT06534619
- Acronym / sponsor ID
- FUI/CTR/2024/18
- Conditions
- Trismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maitland joint mobilization + Rocabdo exercises | Experimental | Procedure: Electrotherapy, Procedure: Rocabado exercises, Procedure: Maitland oscillatory mobilizationsTherapeutic 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. |
| Rocabado exercises | Experimental | Procedure: Electrotherapy, Procedure: Rocabado exercisesParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrotherapyTherapeutic ultrasound: pulse mode - 1:4, frequency 3 MHz, intensity- 0.8 watt/cm2 for about 3-4 minutes. | Procedure or surgery | Maitland joint mobilization + Rocabdo exercises, Rocabado exercises |
| Rocabado exercises6 Rocabado exercises 6 Reps each. | Procedure or surgery | Maitland joint mobilization + Rocabdo exercises, Rocabado exercises |
| Maitland oscillatory mobilizationsMobilizations will be performed in Grade 1 initially and then progressed to Grade 2 and 3. Techniques used are anterior, lateral and inferior glides | Procedure or surgery | Maitland joint mobilization + Rocabdo exercises |
Primary outcome
Pain intensity
Time frame: 1 week
pain will be measured using Numeric pain rating scale
Range of motion
Time frame: 1 week
A Vernier caliper will be used to measure maximal incisal opening (MIO) ≤ 35 mm (ROM)
Functional Performance
Time frame: 1 week
Gothenburg Trismus Questionnaire will be used for assessing functional performance or trismus-related quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy, Rocabado exercises and Maitland oscillatory mobilizations in people with Trismus, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.