Clinical trial NCT06417632: Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns
Official title: Prosthetic Outcomes and Clinical Performance of Two Types of Monolithic Zirconia-based Screw-retained Crowns. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Restoration
Dental Implant
Keywords: implant-supported
patient-reported outcome,
technical, biological outcomes
survival/success rate
single-tooth restorations
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Technical & Biological Outcomes
timeFrame: Baseline, 6 months, 12 months
measure: Survival and Success rate
timeFrame: 6 months, 12 months
measure: Patient reported outcomes
timeFrame: 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The university ofJordan
Study officials:
affiliation: University of Jordan
name: Susan Hattar, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.