AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS

AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS (RANDOMIZED CONTROLLED TRIAL)

Each eligible patient will be randomly into one of two groups:

group A: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.

group B: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.

The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic, China) utilizing printable resin material with codes for which the outcome assessor is kept totally unaware.

For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned.

The splint will be designed and printed in the same workflow as the intervention group.

The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes) will be measured by Medit link by millimeters before the splint insertion.

Study Overview

• Status: Not yet recruiting
• Conditions: TMD
• Intervention / Treatment: Device: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.; Device: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salma A Tantawy, Master of prosthodontics; Phone Number: +20100357380; Email: Salma.tantawy@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) 18-40 years old

  (2) Complete dentition.

  (3) Normal jaw opening.

  (4) Intact teeth.

  (5) No occlusal disorder; stable jaw relation.

  (6) No ongoing dental therapy, such as orthodontic or prosthodontic treatment.

  (7) TMD patients with more than one of following symptoms or signs: myofascial pain and /or pain in the TMJ, myofascial pain and/or pain in the TMJ on palpation, muscles tenderness, headache or earache.

  (8) Patients who had unsuccessfully undergone splint therapy or other TMD treatments in the past were not excluded.

Exclusion Criteria:

• (1) Patients with an unstable occlusion

  (2) Patients with systemic diseases and comorbidities

  (3) Temporomandibular joint lesions found on clinical palpation or medical imaging examination

  (4) Jaw opening less than 3 fingers

  (5) Patients with occlusal dysfunctions

  (6) Patients with severe or moderate periodontitis

  (7) Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic; The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany).	Device: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.; Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.
Active Comparator: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.; For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group.	Device: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique; upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes)	5 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Dermatologic Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: D Ro 3_3_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I am not going to share the IPD for privacy and security of the informations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No