Temporomandibular DisorderNCT04455672
A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder
A study testing splints in people with Temporomandibular Disorder, run by Cairo University.
Trial summary
to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints followed by a stabilizing splints Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 26 Sep 2021
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- • TMDs according to the research diagnostic criteria (RDC)8 which include: i. Painful TMJ audible and palpable click unilateral or bilateral ii. Presence of clicking during opening. iii. TMJ tenderness.
- Fully dentate patients without any malocclusion (natural or restored by fixed prothesis) and good oral hygiene.
- Co-operative patient that should show motivation to follow up.
Who cannot join
- • Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
- Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
- Patients with removable dental prosthesis
About this study
Official title: A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder (A Randomized Cross Over Clinical Trial)
- to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints followed by a stabilizing splints
- Conditions
- Temporomandibular Disorder
- Being tested
- splints
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splintsDevice
- Scaning of the maxillary and mandibular cast in the centric relation.
- The CAD/ CAM splints will be designed using Exocad s.
- The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth.
- The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp.
- Both splints will be printed using Dent2 3D printer and then cured using Dentcure.
- All patient will be asked to wear their spints during sleeping only.
- In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months .
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | patient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint) Receives: Device: splints |
| control group | Active comparator | patient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint) Receives: Device: splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
questionnaire will be used to evaluate the pain
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 posted2 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion26 Jul 2021 (estimated)
- Study completion26 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa mohamed sobhy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455672
- Sponsor's protocol ID
- CEBD-CU-2020-06-29
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder (A Randomized Cross Over Clinical Trial)
- ClinicalTrials.gov ID
- NCT04455672
- Acronym / sponsor ID
- CEBD-CU-2020-06-29
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 26 Jul 2021 (estimated)
- Study completion
- 26 Sep 2021 (estimated)
- First posted
- 2 Jul 2020 (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.
- to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints followed by a stabilizing splints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Device: splintspatient using two types of splints (3d Anterior Rrepositioning Splint then printed stabilizing splint) |
| control group | Active comparator | Device: splintspatient using two types of splints (3d printed stabilizing splint then Anterior Rrepositioning Splint) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • TMDs according to the research diagnostic criteria (RDC)8 which include: i. Painful TMJ audible and palpable click unilateral or bilateral ii. Presence of clicking during opening. iii. TMJ tenderness.
Key exclusion criteria (3 listed)
- • Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
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 |
|---|---|---|
| splints* Scaning of the maxillary and mandibular cast in the centric relation. * The CAD/ CAM splints will be designed using Exocad s. * The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth. * The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp. * Both splints will be printed using Dent2 3D printer and then cured using Dentcure. * All patient will be asked to wear their spints during sleeping only. * In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months . | Device | control group, interventional group |
Primary outcome
pain relief
Time frame: 6 months
questionnaire will be used to evaluate the pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing splints in people with Temporomandibular Disorder, run by Cairo University.
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 3 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
pain relief (time frame: 6 months). 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 2 Jul 2020.