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

NCT06752200 | Not Yet Recruiting DMC

• 1 other identifier: D Ro 3_3_1
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes)

  5 weeks

Study Arms (2)

Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic

EXPERIMENTAL

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 combined digital workflow using a conventional bite technique.

ACTIVE COMPARATOR

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

Interventions

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

Occlusal splints fabricated using a combined digital workflow using a conventional bite technique DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Salma A Tantawy, Master of prosthodontics

CONTACT

+20100357380; Salma.tantawy@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share