Tempromandibular Joint DisordersNCT07074340
Clinical Evaluation of Occlusal Stabilization Splints Fabricated Using Conventional Versus Fully Digital Workflow
A study testing occlusal stabilization splint manufactured with a conventional workflow and occlusal stabilization splint manufactured with Fully-digital workflow in people with Tempromandibular Joint Disorders, run by Cairo University.
Trial summary
Temporomandibular disorders (TMDs) are considered one of the most common diseases in the dental clinic. TMDs are considered a major cause of chronic orofacial pain that affects the patient's daily activities and jaw function. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Tempromandibular Joint Disorders
- What is being tested?
- occlusal stabilization splint manufactured with a conventional workflow and occlusal stabilization splint manufactured with Fully-digital workflow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Mar 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-40 years old.
- Complete dentition
- Intact and stable occlusion.
- 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
Who cannot join
- Patients with severe jaw functional limitations (jaw opening less than 3 fingers).
- Patients suffering from depression, anxiety or mental disorder.
- Patients with ongoing orthodontic treatments.
- History of a recent trauma to face, head or neck.
- Presence of dento-alveolar pathology.
- Presence of sever or moderate periodontitis.
- Patients with ongoing treatment related to TMD.
- -
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: Clinical Evaluation of Occlusal Stabilization Splints Fabricated Using Conventional Versus Fully Digital Workflow Based on Individual Mandibular Movements in TMD PATIENTS.
Temporomandibular disorders (TMDs) are considered one of the most common diseases in the dental clinic. TMDs are considered a major cause of chronic orofacial pain that affects the patient's daily activities and jaw function.
Occlusal splints are the most commonly used treatment modality for TMDs because of their low cost, ease of use and broad indications. Traditional workflow is complicated, technique sensitive and time-consuming as more chair-side time is required for occlusal adjustments . Recently, the revolutionary advances in digital technology have been widely used in prosthodontics, including the use of scanners, jaw tracking devices and CAD-CAM technologies. The fully digital workflow can offer more accuracy and less time consumption . However, literature is still limited and inconclusive regarding the use of fully digital workflows for occlusal splint construction.
Read the detailed description
Stabilization splints (SS) are a major type of occlusal splints that is constructed from hard acrylic and designed to fully cover the maxillary and mandibular dentition in centric occlusion. They provide the patient with a stable occlusion in which the maximum number of simultaneous occlusal contacts, allows an adaptation of the TMJ apparatus and aids in self-repositioning of the condyle in the glenoid fossa.
Conventionally, the occlusal stabilization splint is made by fabrication a wax pattern on surveyed and mounted casts in centric relation then it is processed using lost wax technique to form a clear, heated-cured acrylic resin splint. The splints are thereafter tried intraorally and adjusted to obtain the desired adaptation to the teeth. The process of centric relation registration is complicated, technique sensitive and time- consuming. In addition, the conventional acrylic processing impairs the splint efficacy because of the presence of high porosity, high residual monomer content and shrinkage that affect the dimensional stability and accuracy.
Digital technology in prosthodontics has made revolutionary changes. The use of scanners, jaw tracking devices and CAD-CAM technologies has been involved widely regarding designing and manufacturing. This type of technology has demonstrated greater benefits in terms of dimensional stability, speed, better retention, and greater reproducibility. A study found that construction digitally printed stabilization splints with the use of intra-oral scanner and CAD-CAM showed the same patient improvement when compared to traditional workflow but with significant decrease in the required chairside time. Another concluded that the digital workflow was significantly preferred method among the participants during the construction of stabilization splints.
Recently, digital face bows and jaw tracking devices have been widely used used to record the mandibular movement and the jaw relationship for the fabrication of occlusal devices. These recent digital technologies can reduce the traditional errors and production time present in the conventional method of data acquisition for splints construction, which could improve the accuracy of occlusal splints and decrease the amount of intraoral occlusal adjustments that need to be made. There is a lack in the clinical trials investigating the use of jaw tracking device to acquire personalized articulator parameters to guide the production of occlusal stabilization splints. Hence, this clinical trial is aiming to compare chair side time and treatment outcomes (pain intensity and jaw functional limitation) of stabilization splints fabricated through a fully digital workflow using jaw tracking device for mandibular movement registration versus conventional workflow in patients with (TMDs).
- Conditions
- Tempromandibular Joint Disorders
- Being tested
- occlusal stabilization splint manufactured with a conventional workflow, occlusal stabilization splint manufactured with Fully-digital workflow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal stabilization splint manufactured with a conventional workflowDevice
Heat-cured acrylic resin occlusal stabilization splint
occlusal stabilization splint manufactured with Fully-digital workflowDevice
3D printed occlusal stabilization splints
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Splints manufactured with Conventional workflow | Active comparator | maxillary and mandibular impressions will be made using rubber base impression material and the bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. The occlusal record will be supplemented with a facebow transfer on a semi-adjustable articulator. The stabilization splint will be designed as wax-up then transferred to a duplicate cast for processing into heat-cured acrylic. After processing, the splint will be replaced on the master cast for occlusion refinement Receives: Device: occlusal stabilization splint manufactured with a conventional workflow |
| Occlusal Splints manufactured with fully-digital workflow | Experimental | For the intervention group; an intraoral scanner (Medit i700, South Korea) will be used to scan the maxillary and mandibular dentition and the maxillomandibular relationship in the centric relation position. A Jaw Tracking Device (JMA analyser; Zebris, Germany) will be used to record the jaw motion of the participants. The occlusal stabilization splints will be designed using a designing software (Exocad, USA). This device will be printed with a 3D printer (Creality, China) utilizing printable resin material. Receives: Device: occlusal stabilization splint manufactured with Fully-digital workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chair side Time
For both groups time lapsed during the records visit and fitting visit (T0) will be calculated with a stop watch.
During the records visit, the time used for conventional and digital impressions, facebow record and jaw registration will be recorded in minutes. At fitting visit the necessary individual adjustments of the splints as well as, occlusion and articulation contact will be recorded in minutes.
Measured: "at record visit (baseline) and at delivery visit (during procedure)
Secondary outcomes (1)
pain intensity
Arabic translated instruments from the Axis II questionnaire form will be used to compare treatment outcome: Graded Chronic Pain Scale Version 2.0.
Measured: baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tempromandibular 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Mohamed Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074340
- Sponsor's protocol ID
- PROSR 3-3-12025
- Status last verified
- May 2025
- First submitted
- 29 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: security and privacy
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Occlusal Stabilization Splints Fabricated Using Conventional Versus Fully Digital Workflow Based on Individual Mandibular Movements in TMD PATIENTS.
- ClinicalTrials.gov ID
- NCT07074340
- Acronym / sponsor ID
- PROSR 3-3-12025
- Conditions
- Tempromandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 20 Jul 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.
Temporomandibular disorders (TMDs) are considered one of the most common diseases in the dental clinic. TMDs are considered a major cause of chronic orofacial pain that affects the patient's daily activities and jaw function.
Occlusal splints are the most commonly used treatment modality for TMDs because of their low cost, ease of use and broad indications. Traditional workflow is complicated, technique sensitive and time-consuming as more chair-side time is required for occlusal adjustments . Recently, the revolutionary advances in digital technology have been widely used in prosthodontics, including the use of scanners, jaw tracking devices and CAD-CAM technologies. The fully digital workflow can offer more accuracy and less time consumption . However, literature is still limited and inconclusive regarding the use of fully digital workflows for occlusal splint construction.
Detailed description
Stabilization splints (SS) are a major type of occlusal splints that is constructed from hard acrylic and designed to fully cover the maxillary and mandibular dentition in centric occlusion. They provide the patient with a stable occlusion in which the maximum number of simultaneous occlusal contacts, allows an adaptation of the TMJ apparatus and aids in self-repositioning of the condyle in the glenoid fossa.
Conventionally, the occlusal stabilization splint is made by fabrication a wax pattern on surveyed and mounted casts in centric relation then it is processed using lost wax technique to form a clear, heated-cured acrylic resin splint. The splints are thereafter tried intraorally and adjusted to obtain the desired adaptation to the teeth. The process of centric relation registration is complicated, technique sensitive and time- consuming. In addition, the conventional acrylic processing impairs the splint efficacy because of the presence of high porosity, high residual monomer content and shrinkage that affect the dimensional stability and accuracy.
Digital technology in prosthodontics has made revolutionary changes. The use of scanners, jaw tracking devices and CAD-CAM technologies has been involved widely regarding designing and manufacturing. This type of technology has demonstrated greater benefits in terms of dimensional stability, speed, better retention, and greater reproducibility. A study found that construction digitally printed stabilization splints with the use of intra-oral scanner and CAD-CAM showed the same patient improvement when compared to traditional workflow but with significant decrease in the required chairside time. Another concluded that the digital workflow was significantly preferred method among the participants during the construction of stabilization splints.
Recently, digital face bows and jaw tracking devices have been widely used used to record the mandibular movement and the jaw relationship for the fabrication of occlusal devices. These recent digital technologies can reduce the traditional errors and production time present in the conventional method of data acquisition for splints construction, which could improve the accuracy of occlusal splints and decrease the amount of intraoral occlusal adjustments that need to be made. There is a lack in the clinical trials investigating the use of jaw tracking device to acquire personalized articulator parameters to guide the production of occlusal stabilization splints. Hence, this clinical trial is aiming to compare chair side time and treatment outcomes (pain intensity and jaw functional limitation) of stabilization splints fabricated through a fully digital workflow using jaw tracking device for mandibular movement registration versus conventional workflow in patients with (TMDs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal Splints manufactured with Conventional workflow | Active comparator | Device: occlusal stabilization splint manufactured with a conventional workflowmaxillary and mandibular impressions will be made using rubber base impression material and the bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. The occlusal record will be supplemented with a facebow transfer on a semi-adjustable articulator. The stabilization splint will be designed as wax-up then transferred to a duplicate cast for processing into heat-cured acrylic. After processing, the splint will be replaced on the master cast for occlusion refinement |
| Occlusal Splints manufactured with fully-digital workflow | Experimental | Device: occlusal stabilization splint manufactured with Fully-digital workflowFor the intervention group; an intraoral scanner (Medit i700, South Korea) will be used to scan the maxillary and mandibular dentition and the maxillomandibular relationship in the centric relation position. A Jaw Tracking Device (JMA analyser; Zebris, Germany) will be used to record the jaw motion of the participants. The occlusal stabilization splints will be designed using a designing software (Exocad, USA). This device will be printed with a 3D printer (Creality, China) utilizing printable resin material. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-40 years old.
- Complete dentition
- Intact and stable occlusion.
- 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
Key exclusion criteria (8 listed)
- Patients with severe jaw functional limitations (jaw opening less than 3 fingers).
- Patients suffering from depression, anxiety or mental disorder.
- Patients with ongoing orthodontic treatments.
- History of a recent trauma to face, head or neck.
- Presence of dento-alveolar pathology.
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 stabilization splint manufactured with a conventional workflowHeat-cured acrylic resin occlusal stabilization splint | Device | Occlusal Splints manufactured with Conventional workflow |
| occlusal stabilization splint manufactured with Fully-digital workflow3D printed occlusal stabilization splints | Device | Occlusal Splints manufactured with fully-digital workflow |
Primary outcome
Chair side Time
Time frame: "at record visit (baseline) and at delivery visit (during procedure)
For both groups time lapsed during the records visit and fitting visit (T0) will be calculated with a stop watch. During the records visit, the time used for conventional and digital impressions, facebow record and jaw registration will be recorded in minutes. At fitting visit the necessary individual adjustments of the splints as well as, occlusion and articulation contact will be recorded in minutes.
1 secondary outcome
pain intensity
Time frame: baseline and after 3 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 20 Jul 2025.
- Individual participant dataSharing planned: No. security and privacy
Related trials for Tempromandibular Joint Disorders
Recruiting
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Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
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 stabilization splint manufactured with a conventional workflow and occlusal stabilization splint manufactured with Fully-digital workflow in people with Tempromandibular 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 4 inclusion and 8 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 20 Jul 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 menna shalabi (+201111860078, mennashalabii490@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chair side Time (time frame: "at record visit (baseline) and at delivery visit (during procedure)). 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 20 Jul 2025.