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

Not yet recruiting

• Conditions: Jaw Tracking; Occlusion

• Registration Number: NCT06773728
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-01-15
• Primary Completion: 2025-02-25
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occlusal contacts	From the same appointment	The total number of the true positive and the false positive occlusal contacts between the maxillomandibular relationship obtained from each investigated method is going to be assessed

Secondary Outcome Measures

Name	Time	Method
Patient's acceptance	The visual analog scale records are going to be obtained in the same appointment.	The mean score for each investigated method, as it will be obtained from the visual analog scale, will be assessed.

Trial Locations

Locations (1)

Clinic; 🇬🇷 Athens, Attika, Greece