Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Graded Zirconia Crown, Conventional Zirconia Crown.
- Who it may be relevant to
- Registry conditions: Dental Restoration, Dental Implant. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prosthetic Outcomes and Clinical Performance of Two Types of Monolithic Zirconia-based Screw-retained Crowns. A Randomized Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Other Graded Zirconia Crown
monolithic implant supported crown - Other Conventional Zirconia Crown
monolithic implant supported crown
Primary outcome measures
- Technical & Biological Outcomes [Time frame: Baseline, 6 months, 12 months]
- Survival and Success rate [Time frame: 6 months, 12 months]
- Patient reported outcomes [Time frame: 6 months, 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Inability to provide consent.
- Temporomandibular disorders
- Smoking of more than 10 cigarettes per day
- Untreated caries or periodontal disease of remaining dentition
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- The university ofJordan — Amman
Publications
- 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
Identifiers
NCT: NCT06417632 · Susan Hattar