Accuracy of Centric Relation Recording: Conventional to Optical

NCT07184346 | Not Yet Recruiting

• 1 other identifier: MBRU-HBMCDM-RG2024-05
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Centric Relation Registration

Outcome Measures

Primary Outcomes (1)

• Accuracy of Centric Relation Recording (Trueness and Precision in millimeters)

  Accuracy will be assessed by evaluating trueness and precision of centric relation (CR) records obtained with three techniques: conventional, intraoral scanner, and ModJaw optical jaw tracker. Trueness will be calculated as the mean absolute deviation (mm) between inter-landmark distances on reference STL scans and experimental scans using Geomagic Control X software. Precision will be measured as the standard deviation of repeated inter-landmark distances within each group. Data will be reported as mean ± SD values

  Baseline (Day 5, immediately after centric relation recording).

Study Arms (3)

Accuracy of Centric Relation Record (Control)

EXPERIMENTAL

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.

Other: Control

Accuracy of Centric Relation record IOS

EXPERIMENTAL

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

Device: Intra Oral Scanner

Accuracy of Centric Relation record ModJaw

EXPERIMENTAL

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

Device: Mod Jaw

Interventions

Control OTHER

Control Group

Accuracy of Centric Relation Record (Control)

Intra Oral Scanner DEVICE

Experimental group 1

Accuracy of Centric Relation record IOS

Mod Jaw DEVICE

4 D Jaw Tracker

Accuracy of Centric Relation record ModJaw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Haitham Elbishari, BDS PhD

CONTACT

+971529131315; haitham.elbishari@dubaihealth.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: September 19, 2025
• Study Start: September 30, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share