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临床试验/NCT07184346
NCT07184346尚未招募不适用

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

Mohammed Bin Rashid University of Medicine and Health Sciences0 个研究点目标入组 20 人开始时间: 2025年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Accuracy of Centric Relation Recording (Trueness and Precision in millimeters)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haitham Elbishari

Associate Professor

Mohammed Bin Rashid University of Medicine and Health Sciences

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