Conventional, Additive and Subtractive Occlusal Splints for TMDs

Mansoura University27 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

TMD Disc Displacement

Interventions

Conventional Stabilizing SplintDEVICE

Manual Manufacturing

Milled Stabilizing SplintDEVICE

Subtractive Manufacturing

3D Printed Stabilizing SplintDEVICE

Additive Manufacturing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry - Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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).

Time frame: Baseline (At the time of occlusal splint delivery)

Data from ClinicalTrials.gov

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