Conventional, Additive and Subtractive Occlusal Splints for TMDs (TMD - TMJ - DD)

January 22, 2026 updated by: Mai Ahmed Haggag, Mansoura University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Faculty of Dentistry - Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Splint
Device: Conventional Stabilizing Splint
Manual Manufacturing
Experimental: Milled Splint
Device: Milled Stabilizing Splint
Subtractive Manufacturing
Experimental: 3D Printed Splint
Device: 3D Printed Stabilizing Splint
Additive Manufacturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (At the time of occlusal splint delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A010012024RP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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