Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns

Официальное название

Prosthetic Outcomes and Clinical Performance of Two Types of Monolithic Zirconia-based Screw-retained Crowns. A Randomized Clinical Trial

Обзор

To compare biological, technical, radiographic, and patient-reported outcomes of two types of monolithic zirconia crowns screw-retained to implant. To assess whether the new form of multilayered zirconia crowns will show similar survival and success rate to conventional monolithic Zirconia screw-retained to implants in molar and premolar regions. First Null Hypothesis: Multilayered monolithic zirconia crowns would have similar survival, success rate compared to conventional monolithic zirconia implant supported crowns. Second Null hypothesis: There would be no difference in clinical and patients related outcomes between multilayered and conventional monolithic zirconia implant supported crowns.

Подробное описание

Study design:

A short-randomized controlled trial study, the (PICO) study design: population will be patients from Jordan University Hospital with implants planned for single screw-retained zirconia crowns in the posterior site (premolar or molar), intervention will be the multilayer monolithic screw-retained zirconia crowns over implants, the comparator is the conventional monolithic zirconia crowns over implants, and the main outcomes will be the prosthetic/technical outcomes, survival and success rates in addition to radiographic, patient-reported outcomes, and biological parameters.

Methodology The patients who fulfilled the inclusion/exclusion criteria and entered the study will have a fully digital workflow starting from data acquisition using an intraoral scanner (3Shape TRIOS® 5) , Ti-base abutment design and CAD/CAM milling of the two types of monolithic zirconia blanks (IPS e.max® ZirCAD Prime and IPS e.max® ZirCAD LT).

The fabricated zirconia crowns in both groups will have the same treatment and will be cemented to the Ti-base abutment according to the (APC) concept; alumina airborne-particle abrasion 50-μm at 1 bar for 15-20 seconds, intaglio surface primed using MDP for 60 seconds and air blown for 5 seconds, and finally cemented to the abutment by phosphate monomer resin cement PANAVIA™ V5(Blatz-Alvarez-Compendium-APC-2016, n.d.).

On the other hand, the Ti-base abutment: height will be standardized at 4mm, and the base abutment surface will have blasting with alumina particles of 50 μm at 2-bar pressure for 15-20 seconds at a 10-mm step-over distance at an angle of 45 degrees.

Вмешательства

• Другое Graded Zirconia Crown
  monolithic implant supported crown
• Другое Conventional Zirconia Crown
  monolithic implant supported crown

Первичные конечные точки

• Technical & Biological Outcomes [Срок оценки: Baseline, 6 months, 12 months]
• Survival and Success rate [Срок оценки: 6 months, 12 months]
• Patient reported outcomes [Срок оценки: 6 months, 12 months]

Критерии участия

Критерии включения

• Partially edentulous area with suitable restorative space more than 5.5 mm
• At least 18 years of age
• Opposing natural teeth or fixed restorations supported by teeth or implants.
• Generally good health (ASA I, ASA II)
• Participant complies with good oral hygiene practices (BOP and PI less than 20%)
• Healthy integrated implant/s without signs of periimplantitis in the posterior site planned for single tooth replacement (in premolar or molar areas)
• Patients received bone-level implants, RC Straumann Implants.

Критерии исключения

• Inability to provide consent.
• Temporomandibular disorders
• Smoking of more than 10 cigarettes per day
• Untreated caries or periodontal disease of remaining dentition

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Иордания · 1 центр

• The university ofJordan — Amman

Публикации

• Le M, Dirawi W, Papia E, Larsson C. Clinical Outcome of Three Different Types of Posterior All-Ceramic Crowns. A 3-Year Follow-up of a Multicenter, Randomized, Controlled Clinical Trial. Int J Prosthodont. 2023 Nov 1;36(5):546-553. doi: 10.11607/ijp.8016. PMID 36484665
• Hosseini M, Worsaae N, Gotfredsen K. A 5-year randomized controlled trial comparing zirconia-based versus metal-based implant-supported single-tooth restorations in the premolar region. Clin Oral Implants Res. 2022 Aug;33(8):792-803. doi: 10.1111/clr.13960. Epub 2022 Jun 11. PMID 35633183
• Jung RE, Zembic A, Pjetursson BE, Zwahlen M, Thoma DS. Systematic review of the survival rate and the incidence of biological, technical, and aesthetic complications of single crowns on implants reported in longitudinal studies with a mean follow-up of 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:2-21. doi: 10.1111/j.1600-0501.2012.02547.x. PMID 23062124
• Zhang CN, Zhu Y, Zhang YJ, Jiang YH. Clinical esthetic comparison between monolithic high-translucency multilayer zirconia and traditional veneered zirconia for single implant restoration in maxillary esthetic areas: Prosthetic and patient-centered outcomes. J Dent Sci. 2022 Jul;17(3):1151-1159. doi: 10.1016/j.jds.2022.01.012. Epub 2022 Feb 5. PMID 35784115

Идентификаторы

NCT: NCT06417632 · Susan Hattar

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗