Clinical trial NCT06773728: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Jaw Tracking
Occlusion
Keywords: jaw tracking
dental occlusion
artificial intelligence
maxillomandibular position
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting the university's clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occlusal contacts
timeFrame: From the same appointment
Secondary outcomes:
measure: Patient's acceptance
timeFrame: The visual analog scale records are going to be obtained in the same appointment.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Clinic
state: Attika
Study officials:
References:
citation: 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.
citation: 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. 2024 Jan 18:S0022-3913(23)00836-3. doi: 10.1016/j.prosdent.2023.12.018. Online ahead of print.
citation: 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. 2024 May 17:S0022-3913(24)00240-3. doi: 10.1016/j.prosdent.2024.03.048. Online ahead of print.
citation: 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.