Temporomandibular Joint Disc Displacement, With ReductionNCT05194488
Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction
A study testing Low level laser therapy, Botulinum toxin type A and Anterior repositioning appliance in people with Temporomandibular Joint Disc Displacement, With Reduction, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, With Reduction
- What is being tested?
- Low level laser therapy, Botulinum toxin type A and Anterior repositioning appliance
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 1 Jun 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- TMJ with audible and palpable click.
- Patients with anterior disc displacement as detected by MRI.
- Presence of full or nearly full complement of natural teeth.
Who cannot join
- Patients who have radiographic evidence of degenerative conditions of TMJ.
- Patients who have anterior disc dislocation without reduction.
- Previous history of TMD treatment.
- History of recent trauma.
- The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
- Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
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- Pregnant and lactating females.
- Patients with known allergy to botulinum toxin type A.
- Patients suffering from neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)
Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.
- Being tested
- Low level laser therapy, Botulinum toxin type A, Anterior repositioning appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
Also called LLLT
Patients will receive low-level laser therapy on the temporomandibular joint disc
Also called Botox
Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.
Anterior repositioning applianceDevice
Patients will receive hard maxillary anterior repositioning appliance.
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Not described Receives: Device: Low level laser therapy |
| Botulinum toxin type A | Experimental | Not described Receives: Drug: Botulinum toxin type A |
| Anterior repositioning appliance | Active comparator | Not described Receives: Device: Anterior repositioning appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular joint dysfunction
Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement \& is divided to 4 sections: maximum mouth opening, protrusion \& lateral shift. For mouth opening , value of >40mm scores 0, 30-39mm scores 1 \& <30mm scores 5. Protrusion \& lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is <4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 \& 5 if the subtotal is >4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement \& 20-25: severe involvement
Measured: 3 months
Pain level
This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels.
Measured: 3 months
Temporomandibular joint clinical evaluation
Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start10 Jan 2022
- Primary completion20 May 2022
- Study completion1 Jun 2022
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 Temporomandibular Joint Disc Displacement, With ReductionStudies of the same condition, open and under way.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Mariam M Bahgat, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptNermeen A Rady, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptAhmed M Abdelhamid, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194488
- Sponsor's protocol ID
- IRB 00010556
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rady NA, Bahgat MM, Abdel-Hamid AM. Promising minimally invasive treatment modalities for symptomatic temporomandibular joint disc displacement with reduction: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 1;22(1):547. doi: 10.1186/s12903-022-02579-3.
PubMed 36456937
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05194488
- Acronym / sponsor ID
- IRB 00010556
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Jan 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.
Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Device: Low level laser therapy |
| Botulinum toxin type A | Experimental | Drug: Botulinum toxin type A |
| Anterior repositioning appliance | Active comparator | Device: Anterior repositioning appliance |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- TMJ with audible and palpable click.
- Patients with anterior disc displacement as detected by MRI.
- Presence of full or nearly full complement of natural teeth.
Key exclusion criteria (9 listed)
- Patients who have radiographic evidence of degenerative conditions of TMJ.
- Patients who have anterior disc dislocation without reduction.
- Previous history of TMD treatment.
- History of recent trauma.
- The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
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 |
|---|---|---|
| Low level laser therapyAlso: LLLTPatients will receive low-level laser therapy on the temporomandibular joint disc | Device | Low level laser therapy |
| Botulinum toxin type AAlso: BotoxPatients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance. | Drug | Botulinum toxin type A |
| Anterior repositioning appliancePatients will receive hard maxillary anterior repositioning appliance. | Device | Anterior repositioning appliance |
Primary outcome
Temporomandibular joint dysfunction
Time frame: 3 months
Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement \& is divided to 4 sections: maximum mouth opening, protrusion \& lateral shift. For mouth opening , value of >40mm scores 0, 30-39mm scores 1 \& <30mm scores 5. Protrusion \& lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is <4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 \& 5 if the subtotal is >4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement \& 20-25: severe involvement
Pain level
Time frame: 3 months
This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels.
Temporomandibular joint clinical evaluation
Time frame: 3 months
Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ.
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 4 Dec 2023.
- Derived from this study: PubMed 36456937Rady NA, Bahgat MM, Abdel-Hamid AM. Promising minimally invasive treatment modalities for symptomatic temporomandibular joint disc displacement with reduction: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 1;22(1):547. doi: 10.1186/s12903-022-02579-3.
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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.
Mariam M Bahgat, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Nermeen A Rady, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Ahmed M Abdelhamid, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy, Botulinum toxin type A and Anterior repositioning appliance in people with Temporomandibular Joint Disc Displacement, With Reduction, run by Nourhan M.Aly 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 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: finished, as of the sponsor's last update on 4 Dec 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. 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 dysfunction (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05194488, 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 4 Dec 2023.