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

January 8, 2025 updated by: Panagiotis Ntovas, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Attika
      • Athens, Attika, Greece, 11527
        • Clinic
        • Contact:
          • Papazoglou Efstratios, DDS, MSc,PhD
          • Phone Number: 30 698-512-2220
          • Email: spapazog@otenet.gr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients visiting the university's clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Device: Record occlusal contacts
Register using a digital device (t-scan) the occlusal contacts
Device: Tracking of jaw movement
An optical jaw tracking system (Modjaw, Modjaw) is going to be implemented
Device: Tracking of jaw movement
Jaw tracking will be performed using an optical jaw tracking system (Zebris, Zebris medical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal contacts
Time Frame: 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
From the same appointment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's acceptance
Time Frame: 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.
The visual analog scale records are going to be obtained in the same appointment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

February 25, 2025

Study Completion (Estimated)

March 25, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY0234:

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To further protect patient's data and increase blindness during data analyses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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