TMDNCT06752200
AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS
A study testing Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device. and Occlusal splints fabricated using a combined digital workflow using a conventional bite technique in people with TMD, run by Cairo University.
Trial summary
Each eligible patient will be randomly into one of two groups: group A: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device. group B: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- TMD
- What is being tested?
- Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device. and Occlusal splints fabricated using a combined digital workflow using a conventional bite technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to Jul 2025
- 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
- (1) 18-40 years old
- Complete dentition.
- Normal jaw opening.
- Intact teeth.
- No occlusal disorder; stable jaw relation.
- 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
- (1) Patients with an unstable occlusion
- Patients with systemic diseases and comorbidities
- 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: AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS (RANDOMIZED CONTROLLED TRIAL)
Each eligible patient will be randomly into one of two groups:
group A: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.
Read more
group B: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.
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, China) utilizing printable resin material with codes for which the outcome assessor is kept totally unaware.
For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned.
The splint will be designed and printed in the same workflow as the intervention group.
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes) will be measured by Medit link by millimeters before the splint insertion.
- Conditions
- TMD
- Being tested
- Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device., Occlusal splints fabricated using a combined digital workflow using a conventional bite technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.Device
Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.
Occlusal splints fabricated using a combined digital workflow using a conventional bite techniqueDevice
upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic | 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). Receives: Device: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device. |
| Occlusal splints fabricated using a combined digital workflow using a conventional bite technique. | Active comparator | For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group. Receives: Device: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma abd el fattah abbass sayed tantawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752200
- Sponsor's protocol ID
- D Ro 3_3_1
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 30 Dec 2024
- 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 informations
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS (RANDOMIZED CONTROLLED TRIAL)
- ClinicalTrials.gov ID
- NCT06752200
- Acronym / sponsor ID
- D Ro 3_3_1
- Conditions
- TMD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 30 Dec 2024 (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.
Each eligible patient will be randomly into one of two groups:
group A: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.
group B: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.
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, China) utilizing printable resin material with codes for which the outcome assessor is kept totally unaware.
For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned.
The splint will be designed and printed in the same workflow as the intervention group.
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes) will be measured by Medit link by millimeters before the splint insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic | Experimental | Device: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.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). |
| Occlusal splints fabricated using a combined digital workflow using a conventional bite technique. | Active comparator | Device: Occlusal splints fabricated using a combined digital workflow using a conventional bite techniqueFor the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- (1) 18-40 years old
Key exclusion criteria (7 listed)
- (1) Patients with an unstable occlusion
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 fabricated using a fully digital workflow including the use of a jaw tracking device.Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device. | Device | Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic |
| Occlusal splints fabricated using a combined digital workflow using a conventional bite techniqueupper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group. | Device | Occlusal splints fabricated using a combined digital workflow using a conventional bite technique. |
Primary outcome
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes)
Time frame: 5 weeks
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 30 Dec 2024.
- Individual participant dataSharing planned: No. I am not going to share the IPD for privacy and security of the informations
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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 fabricated using a fully digital workflow including the use of a jaw tracking device. and Occlusal splints fabricated using a combined digital workflow using a conventional bite technique in people with TMD, 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 8 inclusion and 7 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 30 Dec 2024. 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 Salma A Tantawy, Master of prosthodontics (+20100357380, Salma.tantawy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes) (time frame: 5 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 30 Dec 2024.