Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns

NCT06417632 | Not Yet Recruiting

• 1 other identifier: Susan Hattar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration; Dental Implant

Keywords

implant-supported; patient-reported outcome,; technical, biological outcomes; survival/success rate; single-tooth restorations

Outcome Measures

Primary Outcomes (3)

• Technical & Biological Outcomes

  The abutments and restoration will be evaluated clinically by two blinded investigators, according to the modified United States Public Health Service (USPHS) criteria USPHS criteria involve four Scales: Alpha, Bravo, Charlie, Delta The criteria of evaluation include: Restoration fracture, Abutment Fracture, Loosening of the restoration, Screw-access hole restoration, Occlusal Wear, Anatomical Form, Color match, Proximal contact, Occlusal Contact, Marginal Fit, Periodontal parameters.

  Baseline, 6 months, 12 months

• Survival and Success rate

  All patients will be evaluated for success and survival of restorations at 6 months and 1 year after placement of the restorations (Follow-ups). The success rate is defined as the number of restorations that did not change over time. The survival rate is defined as the number of restorations that did not require replacement.

  6 months, 12 months

• Patient reported outcomes

  Patient satisfaction in terms of the shape and shade of the crown, their ability to chew (function) and floss (proximal contact) and their overall satisfaction with the restoration provided will be assessed by a questionnaire based on a five-grade ordinal category scale (extremely satisfied, satisfied, neutral, dissatisfied and extremely dissatisfied). Each patient was asked to fill out the questionnaire themselves to ensure as little bias as possible.

  6 months, 12 months

Study Arms (2)

Graded monolithic Zirconia Crowns

EXPERIMENTAL

3Y-TZP/5Y-TZP zirconia crown

Other: Graded Zirconia Crown

Conventional monolithic Zirconia Crowns

ACTIVE COMPARATOR

3Y-TZP zirconia crowns

Other: Conventional Zirconia Crown

Interventions

Graded Zirconia Crown OTHER

monolithic implant supported crown

Graded monolithic Zirconia Crowns

Conventional Zirconia Crown OTHER

monolithic implant supported crown

Conventional monolithic Zirconia Crowns

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

The university ofJordan

Amman, 11181, Jordan

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Susan Hattar, Professor

  University of Jordan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Hattar, Professor

CONTACT

962795642613; s.hattar@ju.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: May 16, 2024
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)