Evaluation of the Impact of Integrating Dynamic Patient-Specific Motion and Implementing a Jaw Tracking System in the Attribution of the Occlusion in Full-Arch Restorations Through a Digital Workflow: a Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-03-25

Brief Summary

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The maxillomandibular relationship of diagnostic and definitive casts is a fundamental procedure in prosthodontics. Depending on the prosthodontic treatment involvement, different maxillomandibular relationship records can be selected, including maximal intercuspal position (MIP), centric relation (CR) or most comfortable position. Intraoral scanners (IOSs) provide a digital alternative to obtain diagnostic and definitive casts, as well as the maxillomandibular relationship, by acquiring virtual occlusal records.4 Various techniques are available for tracking and recording the mandibular motion of the patient, including mechanical, photographic, radiographic, electromagnetic, ultrasonic-based devices, and optical motion capturing systems. By implementing a digital jaw tracker, patient's individualized mandibular movement can be recorded and combined with intraoral patient's scan, in order to be simulated through the cad software. However, the accuracy of the maxillomandibular relationship has been evaluated only by one study and for one patient. Also, the accuracy to record and replicate of occlusal contacts, acquired by using optical jaw tracking systems has not been evaluated clinically yet. The purpose of the present study was to clinically evaluate the impact of integrating dynamic patient specific-motion and registration, utilizing a digital jaw analyzer (ModJaw), in the attribution of the occlusion.

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Detailed Description

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Patients that are already have been planned for a prosthetic treatment are going to be included in the present research. The records that are used in order to perform an static and a dynamic registration of the occlusion and are standard of care in prosthodontic clinic, will be performed and be obtained by the PI.

In the 1st appointment for each participant a digital impression, as well as a bite registration of the patient will take place in maximal intercuspation(MI) and in the centric relation(CR) implementing am intraoral scanner.(Trios 4, 3Shape).

Patient's individualized dynamic jaw motion will be also recorded by a digital jaw tracking device (ModJaw). In the same appointment patient's contact points will be digitally captured by the scan of the existing teeth or restorations, after the use of an articulating film (8μ , TrollFoil).

Two prototypes utilizing the registration of the jaw tracker in CR and in MCP and two prototypes utilizing the registration that was obtained by the intraoral scanner will be designed. Prototypes will be designed in order to be able to fit over the patient's existing denture.

In the 2nd appointment prototypes will be checked intraorally by implementing an articulating film. An intraoral scan will be performed in order to digitally capture the intraoral markings. Finally patients will be asked to fill out a Visual Analog Scale from 0-100, in order to express "How comfortable they fill their bite, for each one of the prototypes". The questionnaire will be anonymized.

Conditions

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Jaw Tracking Occlusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Record occlusal contacts

Intervention Type DEVICE

Register using a digital device (t-scan) the occlusal contacts

Tracking of jaw movement

Intervention Type DEVICE

An optical jaw tracking system (Modjaw, Modjaw) is going to be implemented

Tracking of jaw movement

Intervention Type DEVICE

Jaw tracking will be performed using an optical jaw tracking system (Zebris, Zebris medical)

Interventions

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Record occlusal contacts

Register using a digital device (t-scan) the occlusal contacts

Intervention Type DEVICE

Tracking of jaw movement

An optical jaw tracking system (Modjaw, Modjaw) is going to be implemented

Intervention Type DEVICE

Tracking of jaw movement

Jaw tracking will be performed using an optical jaw tracking system (Zebris, Zebris medical)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patient age ≥ 18 years Patients with ≥ 10 teeth in each dental arch

Exclusion Criteria

\- Patients with a local or systemic conditions contra-indicating dental treatment (hypertension, a heart attack \< 1 year, a stroke \< 1 year, uncontrolled cardiovascular diseases, uncontrolled diabetes , immunodeficiency, active oral infection as active herpetic lesions etc.) Pregnancy Fully edentulous patients Presence of craniofacial syndromes Patients age \<18 Association with an active orofacial trauma

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes