Dislocation of Temporomandibular Joint TMJNCT05863286
Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
A study testing Botulinum toxin type A in people with Dislocation of Temporomandibular Joint TMJ and Subluxation of Temporomandibular Joint, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of the effect of Botulinum toxin injection on the frequency of luxation and TMJ Pain in patients with TMJ dislocation either chronic recurrent dislocation or subluxation Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dislocation of Temporomandibular Joint TMJ, Subluxation of Temporomandibular Joint
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2022to 31 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with TMJ habitual or recurrent dislocation
- Age ≥ 18 years
- The willingness of the patient to receive relative painful injections and to follow instructions
Who cannot join
- Patients with neurogenic cause of TMJ Hypermobility.
- Drug-induced TMJ Hypermobility
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo university
Cairo, Elmanial, Cairo, 12613
Amr Ehab Shaaban, Bachelor of Dental science, 01111056697, amr.ehab@dentistry.cu.edu.eg
Ahmed Mohamed yousef, 01067941236, dr.ayousef@gmail.com
About this study
Official title: Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation: Double-blind, Randomized, Placebo Controlled Trail Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
Assessment of the effect of Botulinum toxin injection on the frequency of luxation and TMJ Pain in patients with TMJ dislocation either chronic recurrent dislocation or subluxation
Read the detailed description
Diagnostic procedure:
- Patient questionnaire: a questionnaire will be recorded by the examiner including the Chief complaint, Personal data, and Medical history.
- Consent: Informed consent will be obtained from patients to participate in the study.
- Clinical examination: TMJ examination with specific emphasis on the TMJ regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (Inspection and palpation).
- operative procedures:
- The surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion A-Botulinum Toxin Type A injection: BTX-A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length. B-The placebo comparator Injection: Patients in the placebo arm will receive equivalent volumes of placebo solution (Normal Saline).
- Procedure
- With the patient sitting in an upright position on the dental chair, the lateral ptreygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A or normal saline
- The patient will be instructed to remain in an upright position for 6 h (to reduce diffusion into pharyngeal muscles which may cause dysphagia and nasal regurgitation).
- Patients will be recalled weekly during the first month, then monthly after 3 months
- Post-operative care: Paracetamol 1000 mg will be prescribed as needed Any excessive mouth opening should be avoided Soft diets are advised in the first 48 hours after injection
- Being tested
- Botulinum toxin type A
- Keywords
- Botulinum Toxin, Tmj Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botulinum Toxin
Botulinum toxin is produced by the gram-positive, anaerobic, spore-forming bacterium Clostridium botulinum, and is one of the most lethal biological toxins known to man.
Botulinum toxin has seven antigenically different serotypes and exerts a paralytic action by rapidly and strongly binding to presynaptic cholinergic nerve terminals. It is then internalized and ultimately inhibits the exocytosis of acetylcholine by decreasing the frequency of acetylcholine release. Without its nerve supply, the muscle fiber will deteriorate; however, the muscle will regain its strength as the nerves regenerate.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin type A injection in lateral pterygoid muscle | Experimental | Botulinum toxin type A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A Receives: Drug: Botulinum toxin type A |
| Placebo "Saline 0.9%" injection in lateral pterygoid muscle | Placebo comparator | 0.25 ml of normal saline will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with normal saline Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of luxation
Postoperative frequency of luxation is measured by number of luxation per day in organized sheet
Measured: 6 months
Maximum Mouth opening
Postoperative Maximum Mouth opening is measured by digital caliper in follow up intervals" 1 week, 1 month, 3 month, 6 month"
Measured: 6 months
Secondary outcomes (1)
Lateral mandibular movement
Postoperative lateral mandibular movement " side to side movement" is measured by digital caliper in follow up intervals " 1 week, 1 month, 3 month, 6 month"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start30 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dislocation of Temporomandibular Joint TMJStudies 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, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ehab Shaaban, Cairo University
- Investigators
- Hamida Refai, Doctor of dental science, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863286
- Sponsor's protocol ID
- 11 12 22
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
PubMed 21757278
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation: Double-blind, Randomized, Placebo Controlled Trail Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
- ClinicalTrials.gov ID
- NCT05863286
- Acronym / sponsor ID
- 11 12 22
- Keywords
- Botulinum Toxin, Tmj Subluxation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 May 2023 (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.
Assessment of the effect of Botulinum toxin injection on the frequency of luxation and TMJ Pain in patients with TMJ dislocation either chronic recurrent dislocation or subluxation
Detailed description
Diagnostic procedure:
- Patient questionnaire: a questionnaire will be recorded by the examiner including the Chief complaint, Personal data, and Medical history.
- Consent: Informed consent will be obtained from patients to participate in the study.
- Clinical examination: TMJ examination with specific emphasis on the TMJ regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (Inspection and palpation).
- operative procedures:
- The surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion A-Botulinum Toxin Type A injection: BTX-A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length. B-The placebo comparator Injection: Patients in the placebo arm will receive equivalent volumes of placebo solution (Normal Saline).
- Procedure
- With the patient sitting in an upright position on the dental chair, the lateral ptreygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A or normal saline
- The patient will be instructed to remain in an upright position for 6 h (to reduce diffusion into pharyngeal muscles which may cause dysphagia and nasal regurgitation).
- Patients will be recalled weekly during the first month, then monthly after 3 months
- Post-operative care: Paracetamol 1000 mg will be prescribed as needed Any excessive mouth opening should be avoided Soft diets are advised in the first 48 hours after injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin type A injection in lateral pterygoid muscle | Experimental | Drug: Botulinum toxin type ABotulinum toxin type A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length. The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A |
| Placebo "Saline 0.9%" injection in lateral pterygoid muscle | Placebo comparator | Drug: Botulinum toxin type A0.25 ml of normal saline will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length. The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with TMJ habitual or recurrent dislocation
- Age ≥ 18 years
- The willingness of the patient to receive relative painful injections and to follow instructions
Key exclusion criteria (2 listed)
- Patients with neurogenic cause of TMJ Hypermobility.
- Drug-induced TMJ Hypermobility
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 |
|---|---|---|
| Botulinum toxin type AAlso: Botulinum ToxinBotulinum toxin is produced by the gram-positive, anaerobic, spore-forming bacterium Clostridium botulinum, and is one of the most lethal biological toxins known to man. Botulinum toxin has seven antigenically different serotypes and exerts a paralytic action by rapidly and strongly binding to presynaptic cholinergic nerve terminals. It is then internalized and ultimately inhibits the exocytosis of acetylcholine by decreasing the frequency of acetylcholine release. Without its nerve supply, the muscle fiber will deteriorate; however, the muscle will regain its strength as the nerves regenerate. | Drug | Placebo "Saline 0.9%" injection in lateral pterygoid muscle, botulinum toxin type A injection in lateral pterygoid muscle |
Primary outcome
Frequency of luxation
Time frame: 6 months
Postoperative frequency of luxation is measured by number of luxation per day in organized sheet
Maximum Mouth opening
Time frame: 6 months
Postoperative Maximum Mouth opening is measured by digital caliper in follow up intervals" 1 week, 1 month, 3 month, 6 month"
1 secondary outcome
Lateral mandibular movement
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Results publication: PubMed 21757278Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
- Individual participant dataSharing planned: No
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.
Hamida Refai, Doctor of dental science study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A in people with Dislocation of Temporomandibular Joint TMJ and Subluxation of Temporomandibular Joint, 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 3 inclusion and 2 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 22 May 2023. 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 Amr Ehab Shaaban, Bachelor of dental science (01111056697, amr.ehab@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of luxation (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05863286, which also lists 1 linked publication.
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 22 May 2023.