Accuracy of Centric Relation Recording: Conventional to Optical
NCT ID: NCT07184346
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-09-30
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Accuracy of Centric Relation Record (Control)
Centric relation will be recorded using a conventional method with a 2 mm Kois deprogrammer and polyvinyl siloxane (PVS) bite registration. Alginate impressions and facebow records will be taken, mounted on a semi-adjustable articulator, and digitized with a laboratory scanner.
Control
Control Group
Accuracy of Centric Relation record IOS
Centric relation will be recorded using an intraoral scanner. Maxillary and mandibular arches will be scanned, and the Kois deprogrammer with PVS registration will be used to digitally capture mandibular position
Intra Oral Scanner
Experimental group 1
Accuracy of Centric Relation record ModJaw
Centric relation will be recorded using the ModJaw optical jaw tracking system (4D jaw tracker). Previously acquired scans will be imported into ModJaw, and the kois deprogrammer will standardize mandibular position during registration
Mod Jaw
4 D Jaw Tracker
Interventions
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Control
Control Group
Intra Oral Scanner
Experimental group 1
Mod Jaw
4 D Jaw Tracker
Eligibility Criteria
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Inclusion Criteria
2. Presenting with good oral health
3. Fully or partially dentate
Exclusion Criteria
2. Partially dentate with lack of posterior stops
3. Temporomandibular Joint Disorders (TMD)
4. Limited mouth opening
18 Years
ALL
Yes
Sponsors
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Mohammed Bin Rashid University of Medicine and Health Sciences
OTHER
Responsible Party
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Haitham Elbishari
Associate Professor
Central Contacts
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References
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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.
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.
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.
Related Links
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Related Info
Other Identifiers
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MBRU-HBMCDM-RG2024-05
Identifier Type: -
Identifier Source: org_study_id
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