Temporomandibular Joint DisordersNCT06985173
Patient Satisfaction in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow
A study testing Occlusal splints manufactured with fully digital workflow. and Occlusal splints manufactured with Conventional workflow in people with Temporomandibular Joint Disorders, run by Cairo University.
Trial summary
According to published literatures, the prevalence of TMD is approximately 10% in patients over 18 years of age with a considerable proportion being women of reproductive age. The treatment of TMD presents the following goals: decreasing joint and masticatory muscle pain, increasing the range of motion in the… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Occlusal splints manufactured with fully digital workflow. and Occlusal splints manufactured with Conventional workflow
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jan 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.
- Normal jaw opening.
- Intact teeth.
- No ongoing dental therapy, such as orthodontic or prosthodontic treatment.
- TMD patients with more than one of following symptoms or signs: myofascial pain and /or pain in the TMJ, myofascial pain and/or pain in the TMJ on palpation, muscles tenderness, headache or earache.
- Patients who had unsuccessfully undergone splint therapy or other TMD treatments in the past were not excluded.
Who cannot join
- Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, osteoporosis, and patients taking analgesic, muscle relaxant, or anti inflammatory drugs were excluded because such drugs could influence the results.
- Temporomandibular joint lesions found on clinical palpation or medical imaging examination.
- Jaw opening less than 3 fingers.
- Patients with occlusal dysfunctions.
- Patients with severe or moderate periodontitis.
- Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.
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: Patient Satisfaction and Occlusal Adjustments in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow in TMD Patients. (Randomized Controlled Clinical Trial)
According to published literatures, the prevalence of TMD is approximately 10% in patients over 18 years of age with a considerable proportion being women of reproductive age. The treatment of TMD presents the following goals: decreasing joint and masticatory muscle pain, increasing the range of motion in the mandible, preventing degenerative changes in the articulating tissues. Management of TMD can be either conservative or surgical treatments, the conservative treatments include analgesia, medications, physical therapy, occlusal adjustment, splint therapy, localized steam application, and external muscle massage. The occlusal splint therapy is considered a common treatment option for TMD management. Flat stabilization splint is the preferred splint for such cases. It is designed to promote occlusal stability and decrease muscles tension by altering occlusion and allowing complete seating of the condyle in centric relation.
The evolution of digital technology created new era of dentistry that successfully digitalized the traditional workflow of occlusal splints including designing and manufacturing. Furthermore, virtual facebow and dynamic jaw relation record using jaw tracking device are another digital reward. The digital workflow can offer more predictable approach for occlusal splint construction, It could eliminate the traditional technical errors and enhance the occlusal accuracy
Read the detailed description
The traditional workflow of occlusal splints includes, primary impression for both arches, pouring casts, patient deprogramming and centric jaw relation record followed by mounting. Then the occlusal splint is made out of a resin that includes wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint. After that, it is trimmed, polished, and seated back on the duplicate of the invested casts. It is a complicated process and time- consuming constructed followed by occlusal adjustments on the articulator. That traditional approach is time consuming and prone to many technical errors. Such errors are reflected in occlusal discrepancies that are considered critical for the effectiveness of occlusal splint therapy.
Recent advancements in the field of intra-oral scanning (IOS), jaw tracking device for digitally recording the maxillomandibular relationship, maximum intercuspation, centric occlusion and the patient's mandibular motion. This technique incorporates the mandibular motion into the 3-dimensional (3D) virtual patient representation to integrate the 3D dynamic virtual patient visualization and computer-aided design/computer-aided manufacturing (CAD/CAM) may have the potential to compensate for some of the shortcomings of conventional splint therapy and deliver improved clinical results, while simplifying the workflow. Several studies have shown the improved quality and material properties of CAD/CAM splints in comparison to conventional ones, but little of them reported fully digital workflow starting from scanning of maxillary and mandibular teeth, using jaw tracking device to obtain personalized condylar motion parameters and individualized maxillary position to better simulate the actual movement of the patient in the laboratory (Revilla, Marta etal,2022) and Computer-aided design/computer-aided manufacturing (CAD/CAM) in final production of occlusal splints all of these fully digital steps may be possibly reducing the adjustment time for occlusal devices and achieving predictable efficacy.
This study aims to compare the difference, if present in patient satisfaction and the amount of occlusal adjustments in occlusal splints fabricated using fully digital versus conventional workflow.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Occlusal splints manufactured with fully digital workflow., Occlusal splints manufactured with Conventional workflow
- 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.
Occlusal splints manufactured with fully digital workflow.Device
The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device. The acquisition and scanning of the patients are done by using an intra oral scanner and designing them using a designing software. This device will be printed with a 3D printer utilizing printable resin material
Occlusal splints manufactured with Conventional workflowDevice
For the comparator group, maxillary and mandibular impressions will be made with Cavex CA37 alginate impression material (Cavex Holland B.V, Holland), models will be poured with gypsum (Kimberlit, Type IV Dental Stone, Protechno Spain), facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator (Bio-art, A7Plus, Brazil), wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint
| Study group | Role | What they receive |
|---|---|---|
| Occlusal splints manufactured with Conventional workflow | Active comparator | For the comparator group, maxillary and mandibular impressions will be made with alginate impression material, models will be poured with gypsum, facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator, wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint Receives: Device: Occlusal splints manufactured with Conventional workflow |
| Occlusal splints manufactured with fully digital workflow | Experimental | The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic) utilizing printable resin material Receives: Device: Occlusal splints manufactured with fully digital workflow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Primary outcome: patient satisfaction will be recorded using Numeric scales (TMD/NS, 10 cm), this 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 and then after 1 and 3 months. The questioner was translated into Arabic language to be understood by the patients.
Measured: '' Up to 12 weeks''
Secondary outcomes (1)
Amount of occlusal adjustments
Secondary outcome: amount occlusal adjustments (representing 3-dimensional volumetric changes). After finishing of occlusal device, it will be scanned with the scanner (pre-adjustment scan). The scanning will be repeated after adjustment of the occlusal device by the clinician (post-adjustment scan). The STL files of both the pre and post adjustments scans for each occlusal device will be imported to Medit link and the two scans will be superimposed by the "best fit alignment" and "3D compare" functions will be carried out to measure the amount of intraoral occlusal adjustments (in mm) that was performed
Measured: Base line or day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Model description
- The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic) utilizing printable resin material.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Abdelhadi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985173
- Sponsor's protocol ID
- PROSR 3-3-32025
- Status last verified
- Apr 2025
- First submitted
- 6 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am not going to share the IPD for privacy and security of the information.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Occlusal Adjustments in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow in TMD Patients. (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06985173
- Acronym / sponsor ID
- PROSR 3-3-32025
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 22 May 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.
According to published literatures, the prevalence of TMD is approximately 10% in patients over 18 years of age with a considerable proportion being women of reproductive age. The treatment of TMD presents the following goals: decreasing joint and masticatory muscle pain, increasing the range of motion in the mandible, preventing degenerative changes in the articulating tissues. Management of TMD can be either conservative or surgical treatments, the conservative treatments include analgesia, medications, physical therapy, occlusal adjustment, splint therapy, localized steam application, and external muscle massage. The occlusal splint therapy is considered a common treatment option for TMD management. Flat stabilization splint is the preferred splint for such cases. It is designed to promote occlusal stability and decrease muscles tension by altering occlusion and allowing complete seating of the condyle in centric relation.
The evolution of digital technology created new era of dentistry that successfully digitalized the traditional workflow of occlusal splints including designing and manufacturing. Furthermore, virtual facebow and dynamic jaw relation record using jaw tracking device are another digital reward. The digital workflow can offer more predictable approach for occlusal splint construction, It could eliminate the traditional technical errors and enhance the occlusal accuracy
Detailed description
The traditional workflow of occlusal splints includes, primary impression for both arches, pouring casts, patient deprogramming and centric jaw relation record followed by mounting. Then the occlusal splint is made out of a resin that includes wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint. After that, it is trimmed, polished, and seated back on the duplicate of the invested casts. It is a complicated process and time- consuming constructed followed by occlusal adjustments on the articulator. That traditional approach is time consuming and prone to many technical errors. Such errors are reflected in occlusal discrepancies that are considered critical for the effectiveness of occlusal splint therapy.
Recent advancements in the field of intra-oral scanning (IOS), jaw tracking device for digitally recording the maxillomandibular relationship, maximum intercuspation, centric occlusion and the patient's mandibular motion. This technique incorporates the mandibular motion into the 3-dimensional (3D) virtual patient representation to integrate the 3D dynamic virtual patient visualization and computer-aided design/computer-aided manufacturing (CAD/CAM) may have the potential to compensate for some of the shortcomings of conventional splint therapy and deliver improved clinical results, while simplifying the workflow. Several studies have shown the improved quality and material properties of CAD/CAM splints in comparison to conventional ones, but little of them reported fully digital workflow starting from scanning of maxillary and mandibular teeth, using jaw tracking device to obtain personalized condylar motion parameters and individualized maxillary position to better simulate the actual movement of the patient in the laboratory (Revilla, Marta etal,2022) and Computer-aided design/computer-aided manufacturing (CAD/CAM) in final production of occlusal splints all of these fully digital steps may be possibly reducing the adjustment time for occlusal devices and achieving predictable efficacy.
This study aims to compare the difference, if present in patient satisfaction and the amount of occlusal adjustments in occlusal splints fabricated using fully digital versus conventional workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic) utilizing printable resin material.
| Arm | Type | Receives |
|---|---|---|
| Occlusal splints manufactured with Conventional workflow | Active comparator | Device: Occlusal splints manufactured with Conventional workflowFor the comparator group, maxillary and mandibular impressions will be made with alginate impression material, models will be poured with gypsum, facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator, wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint |
| Occlusal splints manufactured with fully digital workflow | Experimental | Device: Occlusal splints manufactured with fully digital workflow.The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic) utilizing printable resin material |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-40 years old
- Complete dentition.
- Normal jaw opening.
- Intact teeth.
- No ongoing dental therapy, such as orthodontic or prosthodontic treatment.
Key exclusion criteria (6 listed)
- Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, osteoporosis, and patients taking analgesic, muscle relaxant, or anti inflammatory drugs were excluded because such drugs could influence the results.
- Temporomandibular joint lesions found on clinical palpation or medical imaging examination.
- Jaw opening less than 3 fingers.
- Patients with occlusal dysfunctions.
- Patients with severe or moderate periodontitis.
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 |
|---|---|---|
| Occlusal splints manufactured with fully digital workflow.The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device. The acquisition and scanning of the patients are done by using an intra oral scanner and designing them using a designing software. This device will be printed with a 3D printer utilizing printable resin material | Device | Occlusal splints manufactured with fully digital workflow |
| Occlusal splints manufactured with Conventional workflowFor the comparator group, maxillary and mandibular impressions will be made with Cavex CA37 alginate impression material (Cavex Holland B.V, Holland), models will be poured with gypsum (Kimberlit, Type IV Dental Stone, Protechno Spain), facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator (Bio-art, A7Plus, Brazil), wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint | Device | Occlusal splints manufactured with Conventional workflow |
Primary outcome
Patient satisfaction
Time frame: '' Up to 12 weeks''
Primary outcome: patient satisfaction will be recorded using Numeric scales (TMD/NS, 10 cm), this 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 and then after 1 and 3 months. The questioner was translated into Arabic language to be understood by the patients.
1 secondary outcome
Amount of occlusal adjustments
Time frame: Base line or day 1
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 22 May 2025.
- Individual participant dataSharing planned: No. I am not going to share the IPD for privacy and security of the information.
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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 Occlusal splints manufactured with fully digital workflow. and Occlusal splints manufactured with Conventional workflow in people with Temporomandibular Joint Disorders, 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 7 inclusion and 6 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 22 May 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 Hadeer Hadi (+201025013956, Hadeer.Abdelhadi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: '' Up to 12 weeks''). 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 22 May 2025.