Temporomandibular DisorderNCT04591899
Clinical and Radiographic Outcomes of CAD/CAM vs Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders
A study testing CAD/CAM splints in people with Temporomandibular Disorder, run by Cairo University.
Trial summary
The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- CAD/CAM splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jun 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients' age ranging from 20 to 50 years.
- TMDs according to the research diagnostic criteria (RDC) for TMD (RDC/TMD) and magnetic resonance imaging (MRI) for confirmation which include:
- Painful TMJ audible and palpable click. ii. No functional mouth limitation. iii. TMJ tenderness. Fully dentate patients without any malocclusion 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 showing bony irregularities e.g. osteophyte as recorded by Magnetic resonance imaging.
- Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
- Any condition that contra-indicates MRI such as patients with pacemakers in heart.
- Patients with removable dental prosthesis
About this study
Official title: Clinical and Radiographic Outcomes of CAD/CAM Versus Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders: A Randomized Clinical Trial
The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction
- Conditions
- Temporomandibular Disorder
- Being tested
- CAD/CAM 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.
CAD/CAM splintsDevice
Each of the maxillary and mandibular cast will scanned alone and then both scanned together in the centric relation using FREEDOM HD scanner1.
The CAD/ CAM splint will be designed using Exocad software; the design will be the same as the conventional one. The surveying will be done by the software and the under-cuts blocked.
The splints will be printed using Dent2 3D printer and then cured using Dentcure. The CAD/CAM splints material will be hard resin from PhotoCentric 3D.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM SS | Experimental | Not described Receives: Device: CAD/CAM splints |
| Conventionally manufactured SS | Active comparator | Not described Receives: Device: CAD/CAM splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction, done by questionnaire having the visual analogue scale
The questionnaire includes the following aspects; headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline 1 and 2 weeks after, then after 1,2 and 3 months. The questioner will be translated into Arabic language to be understood by the patients.
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 posted19 Oct 2020
- Study startDec 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Ahmed Taema, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591899
- Sponsor's protocol ID
- 23091988
- Status last verified
- Aug 2021
- First submitted
- 4 Oct 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of CAD/CAM Versus Conventionally Constructed Occlusal Splints in Patients With Temporomandibular Joint Disorders: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04591899
- Acronym / sponsor ID
- 23091988
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 19 Oct 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.
The aim of this study is to compare between digitally formed occlusal splints versus conventional occlusal splints in patients with TMDs regarding patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM SS | Experimental | Device: CAD/CAM splints |
| Conventionally manufactured SS | Active comparator | Device: CAD/CAM splints |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients' age ranging from 20 to 50 years.
- TMDs according to the research diagnostic criteria (RDC) for TMD (RDC/TMD) and magnetic resonance imaging (MRI) for confirmation which include:
- Painful TMJ audible and palpable click. ii. No functional mouth limitation. iii. TMJ tenderness. Fully dentate patients without any malocclusion and good oral hygiene. Co-operative patient that should show motivation to follow up.
Key exclusion criteria (5 listed)
- Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.
- Patients showing bony irregularities e.g. osteophyte as recorded by Magnetic resonance imaging.
- Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
- Any condition that contra-indicates MRI such as patients with pacemakers in heart.
- Patients with removable dental prosthesis
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 |
|---|---|---|
| CAD/CAM splintsEach of the maxillary and mandibular cast will scanned alone and then both scanned together in the centric relation using FREEDOM HD scanner1. The CAD/ CAM splint will be designed using Exocad software; the design will be the same as the conventional one. The surveying will be done by the software and the under-cuts blocked. The splints will be printed using Dent2 3D printer and then cured using Dentcure. The CAD/CAM splints material will be hard resin from PhotoCentric 3D. | Device | CAD/CAM SS, Conventionally manufactured SS |
Primary outcome
Patient Satisfaction, done by questionnaire having the visual analogue scale
Time frame: 3 months
The questionnaire includes the following aspects; headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline 1 and 2 weeks after, then after 1,2 and 3 months. The questioner will be translated into Arabic language to be understood by the patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Yes
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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 CAD/CAM 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 5 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 4 Aug 2021. 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?
Patient Satisfaction, done by questionnaire having the visual analogue scale (time frame: 3 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 4 Aug 2021.