Temporomandibular Joint DislocationNCT06244134
Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation
A study testing ultrasound guided autologous blood injection and non guided autologous blood injection in people with Temporomandibular Joint Dislocation, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Dislocation
- What is being tested?
- ultrasound guided autologous blood injection and non guided autologous blood injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.
- Necessitating a visit to the emergency room or trained professional to reduce the dislocation.
- Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.
- Maximum mouth opening (MMO) more than 40 mm.
- Unilateral or bilateral.
- Over 18 years of age.
- Both gender Males or females.
Who cannot join
- Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.
- Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .
- Allergy to local anesthetic.
- Severe epilepsy or Parkinson's disease.
- Patient on anti-depressants or anti-psychotics.
- Inability to follow-up the patient during the entire follow-up period.
Show all 9Show fewer
- Patients who had recent fracture at temporomandibular joint level or who had previous surgical interference to temporomandibular joint .
- Refused to sign the written informed consent were also excluded.
- Dystonia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Cairo university
Cairo
Mohamed Abbas, bachelor, 01157370918, mohamed.abbas@dentistry.cu.edu.eg
About this study
Official title: Ultrasound -Guided Versus Conventional Non Guided Autologous Blood Injection For Treatment of Patients With Chronic Recurrent Temporomandibular Joint Dislocation. A Randomized Clinical Trial
The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation
Read the detailed description
All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.
Study group (group A) will be injected with autologous blood with ultrasound guidance.
control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.
The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.
About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.
- Conditions
- Temporomandibular Joint Dislocation
- Being tested
- ultrasound guided autologous blood injection, non guided autologous blood injection
- Keywords
- ultrasound, autologous blood, temporomandibular joint, dislocation
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided autologous blood injectionProcedure or surgery
guided
non guided autologous blood injectionProcedure or surgery
non guided
| Study group | Role | What they receive |
|---|---|---|
| Study group (group A) will be injected with ultrasound guidance in temporomandibular joint . | Active comparator | uses of ultrasound as a guiding tool for temporomandibular joint injection Receives: Procedure: ultrasound guided autologous blood injection |
| control group(group B) conventional non guided injection in temporomandibular joint | Placebo comparator | without ultrasound guidance only anatomical landmark will be followed during injection Receives: Procedure: non guided autologous blood injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum mouth opening
change in Maximum mouth opening (MMO): It's measured (in millimeter) from incisal edge of 11 to 41, in maximum mouth open position using caliper
Measured: at 2weeks, 3months and 6 months post-operative
Secondary outcomes (2)
Frequency of temporomandibular joint dislocation:
number of dislocation per week
Measured: 2weeks, 3 months and 6 months post-operatively
change of pain
measuring pain using visual analogue scale(0-10),higher scores mean worse outcome.
Measured: 2weeks, 3 months and 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jan 2024
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DislocationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abbas Morsy Hussien, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244134
- Sponsor's protocol ID
- 291123
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gagnani SP, Kholakiya YR, Arora A, Bhutia O, Seith A, Khandelwal RK, Roychoudhury A. Ultrasound-guided autologous blood injection in patients with chronic recurrent temporomandibular joint dislocation. Natl J Maxillofac Surg. 2020 Jan-Jun;11(1):34-39. doi: 10.4103/njms.NJMS_57_18. Epub 2020 Jun 18.
PubMed 33041574Pandey SK, Baidya M, Srivastava A, Garg H. Comparison of autologous blood prolotherapy and 25% dextrose prolotherapy for the treatment of chronic recurrent temporomandibular joint dislocation on the basis of clinical parameters: A retrospective study. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):398-404. doi: 10.4103/njms.njms_509_21. Epub 2022 Dec 10.
PubMed 36683930
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound -Guided Versus Conventional Non Guided Autologous Blood Injection For Treatment of Patients With Chronic Recurrent Temporomandibular Joint Dislocation. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06244134
- Acronym / sponsor ID
- 291123
- Conditions
- Temporomandibular Joint Dislocation
- Keywords
- ultrasound, autologous blood, temporomandibular joint, dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Feb 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.
The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation
Detailed description
All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.
Study group (group A) will be injected with autologous blood with ultrasound guidance.
control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.
The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.
About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (group A) will be injected with ultrasound guidance in temporomandibular joint . | Active comparator | Procedure: ultrasound guided autologous blood injectionuses of ultrasound as a guiding tool for temporomandibular joint injection |
| control group(group B) conventional non guided injection in temporomandibular joint | Placebo comparator | Procedure: non guided autologous blood injectionwithout ultrasound guidance only anatomical landmark will be followed during injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.
- Necessitating a visit to the emergency room or trained professional to reduce the dislocation.
- Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.
- Maximum mouth opening (MMO) more than 40 mm.
- Unilateral or bilateral.
Key exclusion criteria (9 listed)
- Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.
- Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .
- Allergy to local anesthetic.
- Severe epilepsy or Parkinson's disease.
- Patient on anti-depressants or anti-psychotics.
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 |
|---|---|---|
| ultrasound guided autologous blood injectionguided | Procedure or surgery | Study group (group A) will be injected with ultrasound guidance in temporomandibular joint . |
| non guided autologous blood injectionnon guided | Procedure or surgery | control group(group B) conventional non guided injection in temporomandibular joint |
Primary outcome
maximum mouth opening
Time frame: at 2weeks, 3months and 6 months post-operative
change in Maximum mouth opening (MMO): It's measured (in millimeter) from incisal edge of 11 to 41, in maximum mouth open position using caliper
2 secondary outcomes
Frequency of temporomandibular joint dislocation:
Time frame: 2weeks, 3 months and 6 months post-operatively
change of pain
Time frame: 2weeks, 3 months and 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 33041574Gagnani SP, Kholakiya YR, Arora A, Bhutia O, Seith A, Khandelwal RK, Roychoudhury A. Ultrasound-guided autologous blood injection in patients with chronic recurrent temporomandibular joint dislocation. Natl J Maxillofac Surg. 2020 Jan-Jun;11(1):34-39. doi: 10.4103/njms.NJMS_57_18. Epub 2020 Jun 18.
- Background: PubMed 36683930Pandey SK, Baidya M, Srivastava A, Garg H. Comparison of autologous blood prolotherapy and 25% dextrose prolotherapy for the treatment of chronic recurrent temporomandibular joint dislocation on the basis of clinical parameters: A retrospective study. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):398-404. doi: 10.4103/njms.njms_509_21. Epub 2022 Dec 10.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided autologous blood injection and non guided autologous blood injection in people with Temporomandibular Joint Dislocation, 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 7 inclusion and 9 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 6 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abbas, bachelor (01157370918, mohamed.abbas@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum mouth opening (time frame: at 2weeks, 3months and 6 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244134, which also lists 2 linked publications.
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 6 Feb 2024.