Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns

NCT ID: NCT06417632

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Dental Restoration Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Graded monolithic Zirconia Crowns

3Y-TZP/5Y-TZP zirconia crown

Group Type EXPERIMENTAL

Graded Zirconia Crown

Intervention Type OTHER

monolithic implant supported crown

Conventional monolithic Zirconia Crowns

3Y-TZP zirconia crowns

Group Type ACTIVE_COMPARATOR

Conventional Zirconia Crown

Intervention Type OTHER

monolithic implant supported crown

Interventions

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Graded Zirconia Crown

monolithic implant supported crown

Intervention Type OTHER

Conventional Zirconia Crown

monolithic implant supported crown

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Susan Hattar

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Hattar, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Jordan

Locations

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The university ofJordan

Amman, , Jordan

Site Status

Countries

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Jordan

Central Contacts

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Susan Hattar, Professor

Role: CONTACT

962795642613

References

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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.

Reference Type BACKGROUND
PMID: 36484665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35633183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35784115 (View on PubMed)

Other Identifiers

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Susan Hattar

Identifier Type: -

Identifier Source: org_study_id

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