TMDTMD - TMJ - DDNCT07371078
Conventional, Additive and Subtractive Occlusal Splints for TMDs
A study testing Conventional Stabilizing Splint, Milled Stabilizing Splint and 3D Printed Stabilizing Splint in people with TMD and Disc Displacement, run by Mansoura University at 1 site in Egypt.
Trial summary
This study is aiming to clinically compare between occlusal splints produced by conventional, subtractive and additive techniques in regard to patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- TMD, Disc Displacement
- What is being tested?
- Conventional Stabilizing Splint, Milled Stabilizing Splint and 3D Printed Stabilizing Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Dec 2025
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients complaining of pain in the orofacial region (either arthrogenous and/or myogenous TMD) in the last 3 months.
- Patients never underwent any type of treatment for TMD's.
- Patients should have at least six natural teeth in each quadrant.
Who cannot join
- Any systemic condition associated with widespread pain (e.g., fibromyalgia).
- Medical history of current drug addiction.
- Patients with psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction With Conventional, Additive and Subtractive Occlusal Splints for TMDs: A Clinical Randomized Trial
This study is aiming to clinically compare between occlusal splints produced by conventional, subtractive and additive techniques in regard to patient satisfaction.
Read the detailed description
The development of a digital (CAD/CAM) technology incorporating three-dimensional (3D) printing and milling enabled the use of different materials and manufacturing techniques. However, it should be noted that most of the evidence is based on in vitro studies with different methodologies, limiting their validity in daily practice. To the authors knowledge, limited data in the literature clinically evaluated occlusal splints produced by conventional, subtractive and additive techniques.
- Conditions
- TMD, Disc Displacement
- Being tested
- Conventional Stabilizing Splint, Milled Stabilizing Splint, 3D Printed Stabilizing Splint
- Keywords
- TMD, DDWR, CAD/CAM, 3D-printed, Occlusal Splint, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Stabilizing SplintDevice
Manual Manufacturing
Milled Stabilizing SplintDevice
Subtractive Manufacturing
3D Printed Stabilizing SplintDevice
Additive Manufacturing
| Study group | Role | What they receive |
|---|---|---|
| Conventional Splint | Experimental | Not described Receives: Device: Conventional Stabilizing Splint |
| Milled Splint | Experimental | Not described Receives: Device: Milled Stabilizing Splint |
| 3D Printed Splint | Experimental | Not described Receives: Device: 3D Printed Stabilizing Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient Satisfaction
Using PSPSQ Questionnaire [The patient satisfaction questionnaire comprised three questions assessed using a 10-point Likert scale (1=extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=slightly dissatisfied, 5=neutral, 6=slightly satisfied, 7=satisfied, 8=very satisfied, 9=extremely satisfied and 10=perfect/strongly satisfied)]
- Scott AA, Hatch JP, Rugh JD, et al: Psychosocial predictors of satisfaction among orthognathic surgery patients. Int J Adult Orthodon Orthognath Surg 15:7, 2000
- J. C. Posnick and J. Wallace, "Complex Orthognathic Surgery: Assessment of Patient Satisfaction," Journal of Oral and Maxillofacial Surgery 66, no. 5 (2008): 934-942.
Measured: 6 months
Secondary outcomes (1)
Time of adjustment
Time of adjustment was measured in minutes
- Algabr, R.S., Alqutaibi, A.Y., Elkadem, A.H., Maher, E.A., \& Kaddah, A.F. (2017). Patient's satisfaction and muscles activity after management of temporomandibular disorders patients using computer-aided design/computer-aided manufacturing versus conventional occlusal splints (randomized clinical trial).
Measured: Baseline (At the time of occlusal splint delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2025
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ahmed Haggag, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371078
- Sponsor's protocol ID
- A010012024RP
- Acronym
- TMD - TMJ - DD
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Conventional, Additive and Subtractive Occlusal Splints for TMDs: A Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT07371078
- Acronym / sponsor ID
- TMD - TMJ - DD / A010012024RP
- Conditions
- TMD, Disc Displacement
- Keywords
- TMD, DDWR, CAD/CAM, 3D-printed, Occlusal Splint, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Jan 2026 (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 study is aiming to clinically compare between occlusal splints produced by conventional, subtractive and additive techniques in regard to patient satisfaction.
Detailed description
The development of a digital (CAD/CAM) technology incorporating three-dimensional (3D) printing and milling enabled the use of different materials and manufacturing techniques. However, it should be noted that most of the evidence is based on in vitro studies with different methodologies, limiting their validity in daily practice. To the authors knowledge, limited data in the literature clinically evaluated occlusal splints produced by conventional, subtractive and additive techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Splint | Experimental | Device: Conventional Stabilizing Splint |
| Milled Splint | Experimental | Device: Milled Stabilizing Splint |
| 3D Printed Splint | Experimental | Device: 3D Printed Stabilizing Splint |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients complaining of pain in the orofacial region (either arthrogenous and/or myogenous TMD) in the last 3 months.
- Patients never underwent any type of treatment for TMD's.
- Patients should have at least six natural teeth in each quadrant.
Key exclusion criteria (3 listed)
- Any systemic condition associated with widespread pain (e.g., fibromyalgia).
- Medical history of current drug addiction.
- Patients with psychiatric disorder.
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 |
|---|---|---|
| Conventional Stabilizing SplintManual Manufacturing | Device | Conventional Splint |
| Milled Stabilizing SplintSubtractive Manufacturing | Device | Milled Splint |
| 3D Printed Stabilizing SplintAdditive Manufacturing | Device | 3D Printed Splint |
Primary outcome
Overall Patient Satisfaction
Time frame: 6 months
Using PSPSQ Questionnaire [The patient satisfaction questionnaire comprised three questions assessed using a 10-point Likert scale (1=extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=slightly dissatisfied, 5=neutral, 6=slightly satisfied, 7=satisfied, 8=very satisfied, 9=extremely satisfied and 10=perfect/strongly satisfied)] * Scott AA, Hatch JP, Rugh JD, et al: Psychosocial predictors of satisfaction among orthognathic surgery patients. Int J Adult Orthodon Orthognath Surg 15:7, 2000 * J. C. Posnick and J. Wallace, "Complex Orthognathic Surgery: Assessment of Patient Satisfaction," Journal of Oral and Maxillofacial Surgery 66, no. 5 (2008): 934-942.
1 secondary outcome
Time of adjustment
Time frame: Baseline (At the time of occlusal splint delivery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for TMD
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Stabilizing Splint, Milled Stabilizing Splint and 3D Printed Stabilizing Splint in people with TMD and Disc Displacement, run by Mansoura University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Patient Satisfaction (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 18 Aug 2026.