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Набор скоро начнётся NCT07184346

Accuracy of Centric Relation Recording: Conventional to Optical

Без фазы С лечением Centric Relation Registration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Control, Intra Oral Scanner, Mod Jaw.
Кому может быть актуально
Состояния в реестре: Centric Relation Registration. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Вмешательства

  • Другое Control
    Control Group
  • Устройство Intra Oral Scanner
    Experimental group 1
  • Устройство Mod Jaw
    4 D Jaw Tracker

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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

Идентификаторы

NCT: NCT07184346 · MBRU-HBMCDM-RG2024-05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗