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Conventional, Additive and Subtractive Occlusal Splints for TMDs

Patient Satisfaction With Conventional, Additive and Subtractive Occlusal Splints for TMDs: A Clinical Randomized Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07371078
Acronym
TMD - TMJ - DD
Enrollment
30
Registered
2026-01-27
Start date
2025-02-01
Completion date
2025-12-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disc Displacement, TMD

Keywords

TMD, DDWR, CAD/CAM, 3D-printed, Occlusal Splint, Patient Satisfaction

Brief summary

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.

Interventions

Manual Manufacturing

DEVICEMilled Stabilizing Splint

Subtractive Manufacturing

DEVICE3D Printed Stabilizing Splint

Additive Manufacturing

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Any systemic condition associated with widespread pain (e.g., fibromyalgia). * Medical history of current drug addiction. * Patients with psychiatric disorder.

Design outcomes

Primary

MeasureTime frameDescription
Overall Patient Satisfaction6 monthsUsing 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.

Secondary

MeasureTime frameDescription
Time of adjustmentBaseline (At the time of occlusal splint delivery)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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026