Clinical trial NCT06982898: Digitalization of Maxillo-mandibular Relation for Arches With Occlusal Support Loss
Official title: Restorative Comparison of Facebow and Simplified Techniques for Digital Jaw Relation Records in Treatment of Occlusal Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prosthetic Treatment
Occlusal Analysis
Digitalism
Keywords: jaw relation
digital dentistry
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Hacettepe University Scientific Research Projects Coordination Unit
First posted: 2025-05-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive two different prosthetic interventions based on different jaw relation record techniques. The outcomes will be compared within the same individuals.
Primary purpose: TREATMENT

Brief summary: Accurate recording of the intermaxillary relationship is crucial for achieving successful restorative outcomes.

In cases of occlusal support loss, determining and recording the intermaxillary relationship becomes more complex.

This study aims to compare the occlusal compatibility of restorations fabricated using either an intraoral scanner or a jaw motion tracking and analysis device for recording the intermaxillary relationship in patients with occlusal support loss.

Detailed description: This study is designed to fabricate bilateral fixed prosthetic restorations in the maxillary posterior region and to evaluate the clinical success, efficiency, and patient satisfaction associated with different intermaxillary relationship recording methods.

The study will compare the clinical outcomes of restorations produced using two techniques:

Group I: Centric relation (CR) determined by bimanual manipulation and recorded with an intraoral scanner.

Group II: Centric relation (CR) determined by neuromuscular deprogramming and recorded with a jaw movement/tracking analysis device.

All tooth preparations will follow standard preparation principles, ensuring minimum material thickness. Preparations will be completed by the investigator (ESK). After preparation, intraoral scans of the upper and lower jaws will be obtained using an intraoral scanner.

Centric relation will be recorded first with bimanual manipulation stabilized with wax, then digitized via intraoral scanning. In a subsequent session, centric relation will be recorded using a neuromuscular deprogrammer and jaw movement tracking analysis.

Both recordings will be sent to a dental laboratory for the fabrication of restorations. A randomization protocol will be applied to vary the adjustment order of the restorations fabricated by each method.

During clinical evaluation:

Distal and mesial proximal contacts will be checked and adjusted as needed.

Internal fit will be evaluated and corrected if necessary.

Occlusal adjustment will be performed using 100 µm and 40 µm articulation papers (Arti-Check micro-thin, Bausch, Cologne, Germany).

After occlusal adjustment:

The adjusted surfaces will be colored, photographed, and measured using ImageJ software to determine the adjusted surface area (in mm²).

Adjustment time and number of articulation paper applications will also be recorded.

These clinical parameters (adjusted area, adjustment time, and number of papers used) will be scored to assess the clinical success of the restorations.

Additionally, patient-reported outcomes will be collected:

Occlusal comfort and technique preference will be evaluated via a Visual Analog Scale (VAS, 0 = complete dissatisfaction, 10 = complete satisfaction) and a method preference survey.

This evaluation aims to determine which technique offers better patient comfort and overall satisfaction.

Eligibility criteria: Inclusion Criteria:

* Voluntary participation after reading and understanding the informed consent form.
* Age between 18 and 65 years with completed growth and development.
* Healthy dental and periodontal condition.
* Presence of bilateral edentulism in the maxillary posterior region leading to occlusal support loss, requiring fixed prosthetic treatment.
* Fixed dentition present in the mandible.

Exclusion Criteria:

* Refusal to voluntarily participate after reading the informed consent form.
* General health condition unsuitable for prosthetic treatment.
* Use of removable prostheses in the mandibular arch.
* Presence of temporomandibular joint dysfunction, orofacial pain, or acute oral disease.
* Presence of a pacemaker or implantable defibrillator.

Primary outcomes:
measure: Adjustment Time for Restoration
timeFrame: 1 year
measure: Adjusted Surface Area of the Restoration
timeFrame: 1 year
measure: Number of Articulation Paper Uses
timeFrame: 1 year
measure: Composite Clinical Success Score of the Restoration
timeFrame: 1 year
Secondary outcomes:
measure: Occlusal Comfort Evaluated Using Visual Analog Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Dentistry
Study officials:
References:
citation: Jasz B, Ambrus S, Garay T, Schmidt P, Hermann P, Kormendi S, Jasz M. Different methods of determining centric relation - comparison with a digital mandibular motion analyser. BMC Oral Health. 2024 Mar 18;24(1):345. doi: 10.1186/s12903-024-04131-x.
citation: Manfredini D, Ercoli C, Poggio CE, Carboncini F, Ferrari M. Centric relation-A biological perspective of a technical concept. J Oral Rehabil. 2023 Nov;50(11):1355-1361. doi: 10.1111/joor.13553. Epub 2023 Jul 11.
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, Kois DE, Kois JC. Utilizing an additively manufactured Kois deprogrammer to record centric relation: A simplified workflow and delivery technique. J Prosthet Dent. 2024 Jul;132(1):20-25. doi: 10.1016/j.prosdent.2022.04.034. Epub 2022 Aug 5.
citation: Radu M, Radu D, Abboud M. Digital recording of a conventionally determined centric relation: A technique using an intraoral scanner. J Prosthet Dent. 2020 Feb;123(2):228-231. doi: 10.1016/j.prosdent.2018.12.004. Epub 2019 May 16.
citation: Abdulateef S, Edher F, Hannam AG, Tobias DL, Wyatt CCL. Clinical accuracy and reproducibility of virtual interocclusal records. J Prosthet Dent. 2020 Dec;124(6):667-673. doi: 10.1016/j.prosdent.2019.11.014. Epub 2020 Feb 1.
citation: Kordass B, Gartner C, Sohnel A, Bisler A, Voss G, Bockholt U, Seipel S. The virtual articulator in dentistry: concept and development. Dent Clin North Am. 2002 Jul;46(3):493-506, vi. doi: 10.1016/s0011-8532(02)00006-x.
citation: Kattadiyil MT, Alzaid AA, Campbell SD. What Materials and Reproducible Techniques May Be Used in Recording Centric Relation? Best Evidence Consensus Statement. J Prosthodont. 2021 Apr;30(S1):34-42. doi: 10.1111/jopr.13321.