Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars

Официальное название

Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to compare the clinical performance of Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM)-milled and 3D-printed composite resin partial-coverage restorations in endodontically treated molars. The main questions it aims to answer are: * Do 3D-printed composite resin partial-coverage restorations show similar clinical performance compared with CAD/CAM-milled composite resin restorations? * Are there differences in survival, success rates, and complications between the two types of restorations over a 3-year follow-up period? Researchers will compare CAD/CAM-milled composite resin restorations with 3D-printed composite resin restorations to evaluate their clinical performance. Participants will: * Receive a partial-coverage restoration (onlay or overlay) in an endodontically treated molar. * Be randomly assigned to receive either a CAD/CAM-milled or a 3D-printed composite resin restoration. * Attend follow-up visits at 12, 24, and 36 months. * Undergo clinical evaluations by two blinded evaluators using the revised FDI criteria and standardized photographic documentation.

Подробное описание

This randomized controlled clinical trial evaluates the clinical performance of indirect composite resin partial-coverage restorations fabricated using subtractive and additive manufacturing technologies in endodontically treated molars.

The study investigates whether 3D-printed composite resin restorations can achieve clinical outcomes comparable to CAD/CAM-milled composite resin restorations when used for cuspal coverage of structurally compromised posterior teeth.

All restorations will be fabricated using a fully digital workflow. Tooth preparation, immediate dentin sealing, digital intraoral scanning, restoration fabrication, and adhesive cementation procedures will be standardized and performed according to a predefined clinical protocol.

The trial will be conducted at Hospital San José, Santiago, Chile, using commercially available restorative materials manufactured by subtractive and additive technologies. Clinical performance will be evaluated according to internationally accepted restorative assessment criteria.

The study aims to generate medium-term clinical evidence regarding the use of 3D-printed composite resin restorations as a potential alternative to conventional CAD/CAM-milled restorations in restorative dentistry.

Вмешательства

• Устройство Milled Composite Resin Onlay/Overlay Restoration
  Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
• Устройство 3D-Printed Composite Resin Onlay/Overlay Restoration
  Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.

Первичные конечные точки

• Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria. [Срок оценки: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)]

Вторичные конечные точки (4)

• Restoration survival rate [Срок оценки: 36 months]
• Restoration success rate [Срок оценки: 36 months]
• Restoration failure rate [Срок оценки: 36 months]
• Clinical complications [Срок оценки: Baseline to 36 months]

Критерии участия

Критерии включения

• Adults aged 18 to 70 years
• Absence of active periodontal disease
• Good oral hygiene (O'Leary plaque index <20%)
• Absence of parafunctional habits (e.g., bruxism, onychophagia)
• Endodontically treated first molars (maxillary or mandibular) with extensive Class II cavities and loss of at least one cusp, requiring onlay or overlay restoration
• Tooth with functional occlusal contact and at least one proximal contact
• Referred from the Endodontics Department of Hospital San José, with endodontic treatment completed at the same institution
• Ability to provide written informed consent
• Ability to attend follow-up visits at 12, 24, and 36 months

Критерии исключения

• Untreated active periodontal disease
• Poor oral hygiene (O'Leary plaque index ≥20%)
• Generalized active caries
• Active parafunctional habits
• Teeth with complete circumferential structural destruction or insufficient coronal tooth structure for onlay/overlay restoration
• Subgingival margins compromising the biologic width
• Known allergy to study materials
• Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Hospital San José — Santiago

Идентификаторы

NCT: NCT07643311 · HSJ-RCT-3DPRINT-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗