TMJ Disc DisorderNCT05627830
Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial
A study testing Prolotherapy in people with TMJ Disc Disorder and Ultrasound Therapy; Complications, run by Cairo University at 1 site in Egypt.
Trial summary
Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint. Rationale for conducting the research: The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder, Ultrasound Therapy; Complications, TMJ
- What is being tested?
- Prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to 1 Oct 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
- Muscles spasm causing TMDs.
- Patients who failed to improve on conservative measures or highly hyperactivity patients.
- Female and male patients age range from 20 to 60 years old.
Who cannot join
- Patients who refused to be included in the research.
- Patients with a systemically diseases or inflammation whether local or generalized.
- Patients with bleeding disorders.
- Patients with unknown dextrose allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.
Rationale for conducting the research:
The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.
- Conditions
- TMJ Disc Disorder, Ultrasound Therapy; Complications, TMJ, Prolotherapy, Internal Derangement, Clicking Tinnitus
- Being tested
- Prolotherapy
- Medical subject headings
- Tinnitus, Chronic Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyProcedure or surgery
Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD. | Experimental | Injection procedure in TMJ Space guided by ultrasound probe the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ).
The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR) Receives: Procedure: Prolotherapy |
| Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD. | Active comparator | Injection procedure in TMJ Space by anatomical land mark (blindly), and we also call it ( conventional prolotherapy ) the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ).
The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR) Receives: Procedure: Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
Measured: Change from Baseline VAS at 4 weeks ( lower score means better outcome)
visual analogue scale
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
Measured: VAS change at 2 months ( lower score means better outcome )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start10 Nov 2022
- Primary completion1 May 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Bader AL-Haj Kheder, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627830
- Sponsor's protocol ID
- 111996
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of volunteers will be shared with the doctors supervising the thesis research to assess the status and results of the scientific research
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05627830
- Acronym / sponsor ID
- 111996
- Conditions
- TMJ Disc Disorder, Ultrasound Therapy; Complications, TMJ, Prolotherapy, Internal Derangement, Clicking Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 28 Nov 2022 (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.
Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.
Rationale for conducting the research:
The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD. | Experimental | Procedure: ProlotherapyInjection procedure in TMJ Space guided by ultrasound probe the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ). The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR) |
| Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD. | Active comparator | Procedure: ProlotherapyInjection procedure in TMJ Space by anatomical land mark (blindly), and we also call it ( conventional prolotherapy ) the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ). The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
- Muscles spasm causing TMDs.
- Patients who failed to improve on conservative measures or highly hyperactivity patients.
- Female and male patients age range from 20 to 60 years old.
Key exclusion criteria (4 listed)
- Patients who refused to be included in the research.
- Patients with a systemically diseases or inflammation whether local or generalized.
- Patients with bleeding disorders.
- Patients with unknown dextrose allergy.
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 |
|---|---|---|
| ProlotherapyProlotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration | Procedure or surgery | Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD., Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD. |
Primary outcome
visual analogue scale
Time frame: Change from Baseline VAS at 4 weeks ( lower score means better outcome)
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
visual analogue scale
Time frame: VAS change at 2 months ( lower score means better outcome )
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
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 19 Sep 2024.
- Individual participant dataSharing planned: No. The data of volunteers will be shared with the doctors supervising the thesis research to assess the status and results of the scientific research
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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 Prolotherapy in people with TMJ Disc Disorder and Ultrasound Therapy; Complications, 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 4 inclusion and 4 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 19 Sep 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 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. 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?
visual analogue scale (time frame: Change from Baseline VAS at 4 weeks ( lower score means better outcome)). 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 19 Sep 2024.