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Not yet recruiting NCT07184346

Accuracy of Centric Relation Recording: Conventional to Optical

No phase Interventional Centric Relation Registration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control, Intra Oral Scanner, Mod Jaw.
Who it may be relevant to
Registry conditions: Centric Relation Registration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Conventional, Digital, and Optical Jaw Tracking Techniques for Recording Centric Relation: An Evaluation of Accuracy

Overview

The current study aims to evaluate the accuracy of different techniques used to record the centric relation. The sample size was determined based on a previous study by Revilla-León et al. (2023), which indicated that 18 participants per group would provide sufficient power for statistical analysis. Eligible participants will be adults above 18 years of age with good oral health who are fully or partially dentate. Exclusion criteria include complete edentulism, absence of posterior stops, temporomandibular joint disorders, and limited mouth opening. Centric relation (CR) will be recorded for all participants using three methods. In Group 1 (Conventional), a 2 mm Lucia jig fabricated from pattern resin (Dura-lay) will be positioned intraorally with the participant reclined at 45°. Polyvinyl siloxane (PVS) bite registration material will be injected bilaterally from the canines to first molars and allowed to set. Alginate impressions, facebow records, and subsequent mounting on a semi-adjustable articulator will be performed, and the casts will be digitized with a laboratory scanner. In Group 2 (Intraoral Scanner), the iTero Element scanner (Align Technology, San Jose, CA) will be used to capture maxillary and mandibular arches. The same Lucia jig will be placed intraorally, and the bite will be digitally captured using the PVS record. In Group 3 (Optical Jaw Tracking), the Modjaw system will be used with previously acquired iTero scans. The Lucia jig will again standardize mandibular position during CR registration. All recordings will be performed by a single experienced prosthodontist to ensure consistency. For accuracy assessment, STL files from all recordings will be imported into Geomagic Control X (3D Systems). Six digital markers will be placed on maxillary and mandibular reference scans at standardized anatomical landmarks (buccal surfaces of first molars, canines, and central incisors). Thirty-six baseline inter-landmark distances will be calculated. Each experimental scan will then be aligned to the reference scan using a best-fit alignment protocol, with marker coordinates transferred from the reference scan to maintain consistency and avoid manual errors. Inter-landmark distances will be recalculated for each experimental scan. Accuracy will be assessed in terms of trueness (mean absolute deviation between reference and experimental measurements) and precision (consistency of distances within each group). Data will be statistically analyzed using analysis of variance (ANOVA), with significance set at p \< 0.05.

Interventions

  • Other Control
    Control Group
  • Device Intra Oral Scanner
    Experimental group 1
  • Device Mod Jaw
    4 D Jaw Tracker

Primary outcome measures

  • Accuracy of Centric Relation Recording (Trueness and Precision in millimeters) [Time frame: Baseline (Day 5, immediately after centric relation recording).]

Eligibility criteria

Inclusion criteria

  • Adults above the age of eighteen years
  • Presenting with good oral health
  • Fully or partially dentate

Exclusion criteria

  • Fully edentulous
  • Partially dentate with lack of posterior stops
  • Temporomandibular Joint Disorders (TMD)
  • Limited mouth opening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ries JM, Grunler C, Wichmann M, Matta RE. Three-dimensional analysis of the accuracy of conventional and completely digital interocclusal registration methods. J Prosthet Dent. 2022 Nov;128(5):994-1000. doi: 10.1016/j.prosdent.2021.03.005. Epub 2021 Apr 19. PMID 33888327
  • Revilla-Leon M, Subramanian SG, Ozcan M, Krishnamurthy VR. Clinical Study of the Influence of Ambient Light Scanning Conditions on the Accuracy (Trueness and Precision) of an Intraoral Scanner. J Prosthodont. 2020 Feb;29(2):107-113. doi: 10.1111/jopr.13135. Epub 2019 Dec 30. PMID 31860144
  • Renne W, Ludlow M, Fryml J, Schurch Z, Mennito A, Kessler R, Lauer A. Evaluation of the accuracy of 7 digital scanners: An in vitro analysis based on 3-dimensional comparisons. J Prosthet Dent. 2017 Jul;118(1):36-42. doi: 10.1016/j.prosdent.2016.09.024. Epub 2016 Dec 23. PMID 28024822

Identifiers

NCT: NCT07184346 · MBRU-HBMCDM-RG2024-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗