NCT06773728

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

January 8, 2025

Last Update Submit

January 8, 2025

Conditions

Keywords

jaw trackingdental occlusionartificial intelligencemaxillomandibular position

Outcome Measures

Primary Outcomes (1)

  • Occlusal contacts

    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 Outcomes (1)

  • Patient's acceptance

    The visual analog scale records are going to be obtained in the same appointment.

Study Arms (1)

Control

Device: Record occlusal contactsDevice: Tracking of jaw movement

Interventions

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

Control

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

Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients visiting the university's clinic

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic

Athens, Attica, 11527, Greece

Location

Related Publications (4)

  • Revilla-Leon M, Fernandez-Estevan L, Barmak AB, Kois JC, Perez-Barquero JA. Accuracy of the maxillomandibular relationship at centric relation position recorded by using 3 different intraoral scanners with or without an optical jaw tracking system: An in vivo pilot study. J Dent. 2023 May;132:104478. doi: 10.1016/j.jdent.2023.104478. Epub 2023 Mar 6.

    PMID: 36889536BACKGROUND
  • Revilla-Leon M, Zeitler JM, Fry E, Kois JC. Digital workflow to measure the mandibular range of motion using different jaw tracking technologies. J Prosthet Dent. 2025 Oct;134(4):1208-1215. doi: 10.1016/j.prosdent.2023.12.018. Epub 2024 Jan 18.

    PMID: 38242763BACKGROUND
  • Kois JC, Zeitler JM, Revilla-Leon M. Use of an optical jaw tracking system to capture the envelope of function when designing interim and definitive prostheses: A dental technique. J Prosthet Dent. 2025 Nov;134(5):1472-1479. doi: 10.1016/j.prosdent.2024.03.048. Epub 2024 May 18.

    PMID: 38762385BACKGROUND
  • Taut M, Chanteux S, Kui A, Buduru R, Negucioiu M, Manziuc M, Gheorghiu I, Hedesiu M, Buduru S, Ilea A. Condylar Parameters and Mandibular Movement Patterns in Bruxers Using an Optical Jaw Tracking System. J Clin Med. 2024 Dec 19;13(24):7761. doi: 10.3390/jcm13247761.

    PMID: 39768684BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Central Study Contacts

Panagiotis C Ntovas, DDS, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD canditate

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

January 15, 2025

Primary Completion

February 25, 2025

Study Completion

March 25, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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

Locations