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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06752200
Enrollment
26
Registered
2024-12-30
Start date
2025-01-01
Completion date
2025-07-31
Last updated
2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMD

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.

Interventions

DEVICEOcclusal 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.

DEVICEOcclusal 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Statistician

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes)5 weeks

Contacts

Primary ContactSalma A Tantawy, Master of prosthodontics
Salma.tantawy@dentistry.cu.edu.eg+20100357380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026