NCT06752200

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• TMD

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2024-12-30
• Last updated: 2024-12-30