TMDNCT06781320
Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints
A study testing stabilization splint in people with TMD and Temporomandibular Disorders (TMD), run by Minia University.
Trial summary
This randomized controlled research aimed to analyse the occlusion and assist the enamel wear before and after using of the stabilization splints produced by the conventional methods with the fully digitally fabricated stabilization splints. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- TMD, Temporomandibular Disorders (TMD)
- What is being tested?
- stabilization splint
- 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
- 26 Jan 2025to 17 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old
- complete dentition
- intact tooth
- no occlusal disorder
- stable jaw relation
- No ongoing dental therapy, such as orthodontic or prosthodontics treatment.
Who cannot join
- pregnant/lactating women
- temporomandibular joint lesions found on clinical palpation or medical imaging examination
- dentoalveolar pathology or ongoing treatment related to TMD
- jaw opening less than 3 fingers
- patients with occlusal dysfunctions
- Patients with severe or moderate periodontitis.
Show all 10Show fewer
- Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.
- Severe jaw functional limitations.
- Removable dentures or partially dentate patients
- Trauma of recent date towards face, head or neck
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints: a Randomized Controlled Clinical Trial
This randomized controlled research aimed to analyse the occlusion and assist the enamel wear before and after using of the stabilization splints produced by the conventional methods with the fully digitally fabricated stabilization splints.
Research question: Will the fully digital stabilization splint offer significantly better occlusal equilibration and enamel wear compared to the conventional stabilization splint? the primary outcome will be Digital occlusal analysis, and secondary outcome will be enamel wear assessment
Read the detailed description
This randomized controlled clinical trial investigates the effectiveness of fully digitally fabricated stabilization splints (FD-SS) versus conventionally manufactured stabilization splints (C-SS) in patients with temporomandibular disorders (TMD). The study focuses on two primary outcomes: digital occlusal analysis and enamel wear assessment over a 6-month period.
Participants are TMD patients aged 18-40 with stable jaw relations and intact dentition, randomly assigned (1:1) to the FD-SS or C-SS group. Digital occlusal analysis is performed using OccluSense technology, which captures bite force distribution and contact points dynamically and statically. Enamel wear is assessed quantitatively using an intraoral scanner paired with Geomagic Control X 3D software for surface matching analysis. Baseline and follow-up STL datasets are compared to quantify volumetric enamel loss with micrometer precision.
In the FD-SS group, fully digital stabilization splints are fabricated using a digital workflow that includes intraoral scanning, jaw tracking with Zebris JMA devices, and CAD/CAM design in Exocad software. Splints are manufactured using 3D printing technology. In the C-SS group, conventional splints are fabricated using alginate impressions, plaster casts, and manual adjustments on a semi-adjustable articulator.
This study aims to advance the understanding of digital technologies in managing TMD, providing evidence for their efficacy in improving occlusal balance and minimizing enamel wear.
- Conditions
- TMD, Temporomandibular Disorders (TMD)
- Being tested
- stabilization splint
- Keywords
- temporomandibular disorder, TMD,, Digital occlusal analysis, enamel wear assessment, stabilization 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.
stabilization splintDevice
the patients will receive a stabilization splint fabricated using a fully digital workflow includes:
Intraoral scanning of maxillary and mandibular arches to create a digital model.
Jaw tracking using the Zebris JMA system to record mandibular movements. CAD design of the splint using Exocad software. Fabrication of the splint via 3D printing technology. The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over 6 months.
Or the patient will receive stabilization splint fabricated using conventional methods. The intervention includes:
Taking alginate impressions of maxillary and mandibular arches to create plaster casts.
Jaw registration using a Lucia jig and semi-adjustable articulator for proper occlusal adjustment.
Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin. The C-SS is designed to achieve occlusal stabilization and symptom relief for TMD patients over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Fully Digital Stabilization Splint (FD-SS) | Experimental | Description:
Participants in this group will receive a stabilization splint fabricated using a fully digital workflow. The intervention includes:
* Intraoral scanning of the maxillary and mandibular arches to create a digital model.
* Jaw tracking using the Zebris JMA system to record mandibular movements.
* CAD design of the splint using Exocad software.
* Fabrication: 3D printing technology to manufacture the splint.
Purpose:
The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over a 6-month period.
Device Name: Fully Digital Stabilization Splint (FD-SS) Receives: Device: stabilization splint |
| Conventional Stabilization Splint (C-SS) | Active comparator | Description:
Participants in this group will receive a stabilization splint fabricated using conventional methods. The intervention includes:
* Taking alginate impressions of the maxillary and mandibular arches to create plaster casts.
* Jaw registration using a Lucia jig and a semi-adjustable articulator for occlusal adjustment.
* Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin.
Purpose:
The C-SS is designed to achieve occlusal stabilization and provide symptom relief for patients with temporomandibular disorders (TMD) over 6 months.
Device Name: Conventional Stabilization Splint (C-SS) Receives: Device: stabilization splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).
Occlusal Force Measurement:
- Measured using OccluSense in Newtons (N)
Measured: 6 months
Secondary outcomes (1)
Tooth Wear Measurement using an intraoral scanner
Comparison of STL datasets using Geomagic Control X software.
- Measured as % of surface overlap or deviation in microns.
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 posted17 Jan 2025
- Study start26 Jan 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion17 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by Minia 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sawi Mohamed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781320
- Sponsor's protocol ID
- 112/498
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06781320
- Acronym / sponsor ID
- 112/498
- Conditions
- TMD, Temporomandibular Disorders (TMD)
- Keywords
- temporomandibular disorder, TMD,, Digital occlusal analysis, enamel wear assessment, stabilization splints
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 26 Jan 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 17 Jul 2026 (estimated)
- First posted
- 17 Jan 2025 (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.
This randomized controlled research aimed to analyse the occlusion and assist the enamel wear before and after using of the stabilization splints produced by the conventional methods with the fully digitally fabricated stabilization splints.
Research question: Will the fully digital stabilization splint offer significantly better occlusal equilibration and enamel wear compared to the conventional stabilization splint? the primary outcome will be Digital occlusal analysis, and secondary outcome will be enamel wear assessment
Detailed description
This randomized controlled clinical trial investigates the effectiveness of fully digitally fabricated stabilization splints (FD-SS) versus conventionally manufactured stabilization splints (C-SS) in patients with temporomandibular disorders (TMD). The study focuses on two primary outcomes: digital occlusal analysis and enamel wear assessment over a 6-month period.
Participants are TMD patients aged 18-40 with stable jaw relations and intact dentition, randomly assigned (1:1) to the FD-SS or C-SS group. Digital occlusal analysis is performed using OccluSense technology, which captures bite force distribution and contact points dynamically and statically. Enamel wear is assessed quantitatively using an intraoral scanner paired with Geomagic Control X 3D software for surface matching analysis. Baseline and follow-up STL datasets are compared to quantify volumetric enamel loss with micrometer precision.
In the FD-SS group, fully digital stabilization splints are fabricated using a digital workflow that includes intraoral scanning, jaw tracking with Zebris JMA devices, and CAD/CAM design in Exocad software. Splints are manufactured using 3D printing technology. In the C-SS group, conventional splints are fabricated using alginate impressions, plaster casts, and manual adjustments on a semi-adjustable articulator.
This study aims to advance the understanding of digital technologies in managing TMD, providing evidence for their efficacy in improving occlusal balance and minimizing enamel wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully Digital Stabilization Splint (FD-SS) | Experimental | Device: stabilization splintDescription: Participants in this group will receive a stabilization splint fabricated using a fully digital workflow. The intervention includes: * Intraoral scanning of the maxillary and mandibular arches to create a digital model. * Jaw tracking using the Zebris JMA system to record mandibular movements. * CAD design of the splint using Exocad software. * Fabrication: 3D printing technology to manufacture the splint. Purpose: The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over a 6-month period. Device Name: Fully Digital Stabilization Splint (FD-SS) |
| Conventional Stabilization Splint (C-SS) | Active comparator | Device: stabilization splintDescription: Participants in this group will receive a stabilization splint fabricated using conventional methods. The intervention includes: * Taking alginate impressions of the maxillary and mandibular arches to create plaster casts. * Jaw registration using a Lucia jig and a semi-adjustable articulator for occlusal adjustment. * Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin. Purpose: The C-SS is designed to achieve occlusal stabilization and provide symptom relief for patients with temporomandibular disorders (TMD) over 6 months. Device Name: Conventional Stabilization Splint (C-SS) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-40 years old
- complete dentition
- intact tooth
- no occlusal disorder
- stable jaw relation
Key exclusion criteria (10 listed)
- pregnant/lactating women
- temporomandibular joint lesions found on clinical palpation or medical imaging examination
- dentoalveolar pathology or ongoing treatment related to TMD
- jaw opening less than 3 fingers
- patients with occlusal dysfunctions
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 |
|---|---|---|
| stabilization splintthe patients will receive a stabilization splint fabricated using a fully digital workflow includes: Intraoral scanning of maxillary and mandibular arches to create a digital model. Jaw tracking using the Zebris JMA system to record mandibular movements. CAD design of the splint using Exocad software. Fabrication of the splint via 3D printing technology. The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over 6 months. Or the patient will receive stabilization splint fabricated using conventional methods. The intervention includes: Taking alginate impressions of maxillary and mandibular arches to create plaster casts. Jaw registration using a Lucia jig and semi-adjustable articulator for proper occlusal adjustment. Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin. The C-SS is designed to achieve occlusal stabilization and symptom relief for TMD patients over 6 months. | Device | Conventional Stabilization Splint (C-SS), Fully Digital Stabilization Splint (FD-SS) |
Primary outcome
1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).
Time frame: 6 months
Occlusal Force Measurement: * Measured using OccluSense in Newtons (N)
1 secondary outcome
Tooth Wear Measurement using an intraoral scanner
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing stabilization splint in people with TMD and Temporomandibular Disorders (TMD), run by Minia 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 17 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Sawi Mohamed Sawi, Assistant lecturer (00201113669910, drmohamedelsawi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N). (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 17 Jan 2025.