Digitalization of Maxillo-mandibular Relation for Arches With Occlusal Support Loss

Официальное название

Restorative Comparison of Facebow and Simplified Techniques for Digital Jaw Relation Records in Treatment of Occlusal Rehabilitation

Обзор

Accurate recording of the intermaxillary relationship is crucial for achieving successful restorative outcomes. In cases of occlusal support loss, determining and recording the intermaxillary relationship becomes more complex. This study aims to compare the occlusal compatibility of restorations fabricated using either an intraoral scanner or a jaw motion tracking and analysis device for recording the intermaxillary relationship in patients with occlusal support loss.

Подробное описание

This study is designed to fabricate bilateral fixed prosthetic restorations in the maxillary posterior region and to evaluate the clinical success, efficiency, and patient satisfaction associated with different intermaxillary relationship recording methods.

The study will compare the clinical outcomes of restorations produced using two techniques:

Group I: Centric relation (CR) determined by bimanual manipulation and recorded with an intraoral scanner.

Group II: Centric relation (CR) determined by neuromuscular deprogramming and recorded with a jaw movement/tracking analysis device.

All tooth preparations will follow standard preparation principles, ensuring minimum material thickness. Preparations will be completed by the investigator (ESK). After preparation, intraoral scans of the upper and lower jaws will be obtained using an intraoral scanner.

Centric relation will be recorded first with bimanual manipulation stabilized with wax, then digitized via intraoral scanning. In a subsequent session, centric relation will be recorded using a neuromuscular deprogrammer and jaw movement tracking analysis.

Both recordings will be sent to a dental laboratory for the fabrication of restorations. A randomization protocol will be applied to vary the adjustment order of the restorations fabricated by each method.

During clinical evaluation:

Distal and mesial proximal contacts will be checked and adjusted as needed.

Internal fit will be evaluated and corrected if necessary.

Occlusal adjustment will be performed using 100 µm and 40 µm articulation papers (Arti-Check micro-thin, Bausch, Cologne, Germany).

After occlusal adjustment:

The adjusted surfaces will be colored, photographed, and measured using ImageJ software to determine the adjusted surface area (in mm²).

Adjustment time and number of articulation paper applications will also be recorded.

These clinical parameters (adjusted area, adjustment time, and number of papers used) will be scored to assess the clinical success of the restorations.

Additionally, patient-reported outcomes will be collected:

Occlusal comfort and technique preference will be evaluated via a Visual Analog Scale (VAS, 0 = complete dissatisfaction, 10 = complete satisfaction) and a method preference survey.

This evaluation aims to determine which technique offers better patient comfort and overall satisfaction.

Вмешательства

• Процедура Fixed prosthesis with bimanual CR and intraoral scan
  Tooth-supported fixed prostheses were fabricated using centric relation records obtained by two different methods: 1. Bimanual manipulation technique, with jaw relation records captured using an intraoral scanner. 2. Neuromuscular deprogramming technique, with jaw relation records obtained using a jaw movement tracking and analysis device.

Первичные конечные точки

• Adjustment Time for Restoration [Срок оценки: 1 year]
• Adjusted Surface Area of the Restoration [Срок оценки: 1 year]
• Number of Articulation Paper Uses [Срок оценки: 1 year]
• Composite Clinical Success Score of the Restoration [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Occlusal Comfort Evaluated Using Visual Analog Scale [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Voluntary participation after reading and understanding the informed consent form.
• Age between 18 and 65 years with completed growth and development.
• Healthy dental and periodontal condition.
• Presence of bilateral edentulism in the maxillary posterior region leading to occlusal support loss, requiring fixed prosthetic treatment.
• Fixed dentition present in the mandible.

Критерии исключения

• Refusal to voluntarily participate after reading the informed consent form.
• General health condition unsuitable for prosthetic treatment.
• Use of removable prostheses in the mandibular arch.
• Presence of temporomandibular joint dysfunction, orofacial pain, or acute oral disease.
• Presence of a pacemaker or implantable defibrillator.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Hacettepe University, Faculty of Dentistry — Ankara

Публикации

• Jasz B, Ambrus S, Garay T, Schmidt P, Hermann P, Kormendi S, Jasz M. Different methods of determining centric relation - comparison with a digital mandibular motion analyser. BMC Oral Health. 2024 Mar 18;24(1):345. doi: 10.1186/s12903-024-04131-x. PMID 38500122
• Manfredini D, Ercoli C, Poggio CE, Carboncini F, Ferrari M. Centric relation-A biological perspective of a technical concept. J Oral Rehabil. 2023 Nov;50(11):1355-1361. doi: 10.1111/joor.13553. Epub 2023 Jul 11. PMID 37394665
• Revilla-Leon M, Fernandez-Estevan L, Barmak AB, Kois JC, Perez-Barquero JA. Accuracy of the maxillomandibular relationship at centric relation position recorded by using 3 different intraoral scanners with or without an optical jaw tracking system: An in vivo pilot study. J Dent. 2023 May;132:104478. doi: 10.1016/j.jdent.2023.104478. Epub 2023 Mar 6. PMID 36889536
• Revilla-Leon M, Zeitler JM, Kois DE, Kois JC. Utilizing an additively manufactured Kois deprogrammer to record centric relation: A simplified workflow and delivery technique. J Prosthet Dent. 2024 Jul;132(1):20-25. doi: 10.1016/j.prosdent.2022.04.034. Epub 2022 Aug 5. PMID 35934572
• Radu M, Radu D, Abboud M. Digital recording of a conventionally determined centric relation: A technique using an intraoral scanner. J Prosthet Dent. 2020 Feb;123(2):228-231. doi: 10.1016/j.prosdent.2018.12.004. Epub 2019 May 16. PMID 31104810
• Abdulateef S, Edher F, Hannam AG, Tobias DL, Wyatt CCL. Clinical accuracy and reproducibility of virtual interocclusal records. J Prosthet Dent. 2020 Dec;124(6):667-673. doi: 10.1016/j.prosdent.2019.11.014. Epub 2020 Feb 1. PMID 32014284
• Kordass B, Gartner C, Sohnel A, Bisler A, Voss G, Bockholt U, Seipel S. The virtual articulator in dentistry: concept and development. Dent Clin North Am. 2002 Jul;46(3):493-506, vi. doi: 10.1016/s0011-8532(02)00006-x. PMID 12222093
• Kattadiyil MT, Alzaid AA, Campbell SD. What Materials and Reproducible Techniques May Be Used in Recording Centric Relation? Best Evidence Consensus Statement. J Prosthodont. 2021 Apr;30(S1):34-42. doi: 10.1111/jopr.13321. PMID 33783085

Идентификаторы

NCT: NCT06982898 · KA-24002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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