Conventional, Additive and Subtractive Occlusal Splints for TMDs

NCT07371078 | Completed DMC

• 1 other identifier: A010012024RP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TMD; Disc Displacement

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Time of adjustment

  Baseline (At the time of occlusal splint delivery)

Study Arms (3)

Conventional Splint

EXPERIMENTAL

Device: Conventional Stabilizing Splint

Milled Splint

EXPERIMENTAL

Device: Milled Stabilizing Splint

3D Printed Splint

EXPERIMENTAL

Device: 3D Printed Stabilizing Splint

Interventions

Milled Stabilizing Splint DEVICE

Subtractive Manufacturing

Milled Splint

3D Printed Stabilizing Splint DEVICE

Additive Manufacturing

3D Printed Splint

Conventional Stabilizing Splint DEVICE

Manual Manufacturing

Conventional Splint

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry - Mansoura University

Al Mansurah, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)