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NCT Number: NCT06752200

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

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.

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Key information

Conditions

TMD

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 5 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Salma A Tantawy, Master of prosthodontics

CONTACT

[email protected]

+20100357380

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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