Temporomandibular PainNCT06675149
Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral Surgery
A study testing Diacutaneus fibrolysis, Transcutaneous electrical nerve stimulation and Massage in people with Temporomandibular Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Pain
- What is being tested?
- Diacutaneus fibrolysis, Transcutaneous electrical nerve stimulation and Massage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2024to 27 Feb 2025
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages of patients will be ranged from 18 to 40 years.
- All patients will have Oral and Maxillofacial Surgery.
- All patients will be referred by a surgeon before starting the study procedure.
- All participants will have pain and trismus in the jaw,
- The participants will be also cleared for periodontal issues.
- All patients will enter the study having their informed consent
Who cannot join
- Patients with associated vascular injuries requiring arterial repair.
- Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition
- Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat
- Patient with present neurologic or cognitive deficit.
- Patients with history of previously failed surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral and Maxillofacial Surgery
This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years.
- Conditions
- Temporomandibular Pain
- Being tested
- Diacutaneus fibrolysis, Transcutaneous electrical nerve stimulation, Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacutaneus fibrolysisDevice
Also called Hook measurements
Material : Stainless steel large angle and small long angle: length 22cm x height 6cm x width 2cm. Weight: 70 grams
Transcutaneous electrical nerve stimulationDevice
Also called TENS
physical therapy electrical modality
MassageProcedure or surgery
manual therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | This group includes 30 patients who will receive 4 weeks(3times/week) DiacutaneusFibrolysis in addition to post-surgical traditional physiotherapy . Receives: Device: Diacutaneus fibrolysis; Device: Transcutaneous electrical nerve stimulation; Procedure: Massage |
| Group A | Placebo comparator | This group will includes 30 patients who will receive 4 weeks (3times/week) post-surgical traditional physiotherapy (TENS , massage , range of motion exercise ) . Receives: Device: Transcutaneous electrical nerve stimulation; Procedure: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
temporomandibular joint pain
pain is assessed Pressure pain threshold(PPT) will be obtained with the aid of an algometer by applying pressure to the masseter and to the anterior, middle, and posterior temporalis, increasing pressure until the patient will feel that the pressure will become unpleasant or "painful .
Measured: pre intervention and re assessed after 1 month
Trismus
Trismus is assessed by caliper
Measured: pre intervention and re assessed after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start20 Aug 2024
- Primary completion20 Sep 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Elsayed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675149
- Sponsor's protocol ID
- 012/005335
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral and Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT06675149
- Acronym / sponsor ID
- 012/005335
- Conditions
- Temporomandibular Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 5 Nov 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.
This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Device: Diacutaneus fibrolysis, Device: Transcutaneous electrical nerve stimulation, Procedure: MassageThis group includes 30 patients who will receive 4 weeks(3times/week) DiacutaneusFibrolysis in addition to post-surgical traditional physiotherapy . |
| Group A | Placebo comparator | Device: Transcutaneous electrical nerve stimulation, Procedure: MassageThis group will includes 30 patients who will receive 4 weeks (3times/week) post-surgical traditional physiotherapy (TENS , massage , range of motion exercise ) . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages of patients will be ranged from 18 to 40 years.
- All patients will have Oral and Maxillofacial Surgery.
- All patients will be referred by a surgeon before starting the study procedure.
- All participants will have pain and trismus in the jaw,
- The participants will be also cleared for periodontal issues.
Key exclusion criteria (5 listed)
- Patients with associated vascular injuries requiring arterial repair.
- Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition
- Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat
- Patient with present neurologic or cognitive deficit.
- Patients with history of previously failed surgeries.
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 |
|---|---|---|
| Diacutaneus fibrolysisAlso: Hook measurementsMaterial : Stainless steel large angle and small long angle: length 22cm x height 6cm x width 2cm. Weight: 70 grams | Device | Group B |
| Transcutaneous electrical nerve stimulationAlso: TENSphysical therapy electrical modality | Device | Group A, Group B |
| Massagemanual therapy intervention | Procedure or surgery | Group A, Group B |
Primary outcome
temporomandibular joint pain
Time frame: pre intervention and re assessed after 1 month
pain is assessed Pressure pain threshold(PPT) will be obtained with the aid of an algometer by applying pressure to the masseter and to the anterior, middle, and posterior temporalis, increasing pressure until the patient will feel that the pressure will become unpleasant or "painful .
Trismus
Time frame: pre intervention and re assessed after 1 month
Trismus is assessed by caliper
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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 Diacutaneus fibrolysis, Transcutaneous electrical nerve stimulation and Massage in people with Temporomandibular Pain, run by Cairo University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 3 Mar 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
temporomandibular joint pain (time frame: pre intervention and re assessed after 1 month). The study lists 2 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 3 Mar 2025.