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NCT Number: NCT07371078

Conventional, Additive and Subtractive Occlusal Splints for TMDs

This study is aiming to clinically compare between occlusal splints produced by conventional, subtractive and additive techniques in regard to patient satisfaction.

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Key information

Conditions

TMD Behavior Disc Displacement Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry - Mansoura University

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Stabilizing Splint

Device

Manual Manufacturing

Milled Stabilizing Splint

Device

Subtractive Manufacturing

3D Printed Stabilizing Splint

Device

Additive Manufacturing

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time of adjustment

    Time frame: Baseline (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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: TMD - TMJ - DD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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