Monolithic Zirconia With CAD/CAM Titanium Abutments: A 5-year Prospective Case Series Study

Monolithic Zirconia Single Tooth Implant-supported Restorations With CAD/CAM Titanium Abutments in the Posterior Region: A 5-year Prospective Case Series Study

• Background There is a growing interest in restoring function in the posterior maxilla and mandible with dental implants. Next to this, these implants must be restored with crowns which are subject to minimal complications. Companies have introduced the option of screw-retaining and zirconia as crown material. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are scarce. Even more, 5-years data are lacking.
• Main research question To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible. The primary objective of the study is marginal bone level changes by radiological assessments at 5-years follow-up. Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.
• Design (including population, confounders/outcomes) The study design is an observational study of a group of patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region. Outcomes: primary outcome is the change in marginal peri-implant bone level 5 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.

Study Overview

• Status: Enrolling by invitation
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Device: Astra Tech Osseospeed EV® dental implant

Detailed Description

• Introduction and rationale Nowadays, the use of dental implants for oral rehabilitation is a generally accepted treatment modality. During the first years of implant dentistry, dental implants were used mainly for the restoration of edentulous mandibles with implant-supported prostheses. Yet, there is a shift towards the application of dental implants for single-tooth replacements, supported by long-term studies reporting excellent survival rates. Not only in the aesthetic region, but also in the posterior maxilla and mandible there is a growing interest in restoring function. Dental implants show a good performance in the posterior region; in recent years attention has been shifted towards a better initial stability to reduce treatment time. Next to this, implants must be restored with crowns which are subject to minimal complications. Specially for the posterior region, companies have introduced the option of screw-retaining and zirconia as crown material, of which less technical complications are mentioned. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are scarce and 5-years results are lacking.

RESEARCH QUESTION To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible after a 5-years follow-up.

STUDY DESIGN The study design is an observational study of a group of 50 patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region.

• Study Type: Observational
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713AV
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population: Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with a dental implant and a screw-retained implant-supported zirconia restoration because of having a missing tooth in the posterior region. At the time of treatment:

• The patient was 18 years or older;
• The missing tooth was a premolar or molar in maxilla or mandible;

Description

Inclusion Criteria:

• Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with a dental implant and a screw-retained implant-supported zirconia restoration because of having a missing tooth in the posterior region. At the time of treatment:
• The patient was 18 years or older;
• The missing tooth was a premolar or molar in maxilla or mandible;
• Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8 mm and at least 4.2 mm in diameter with initial stability > 45 Ncm
• The implant site was free from infection;
• Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
• Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
• The patient was capable of understanding and giving informed consent.

Exclusion Criteria:

• Medical and general contraindications for the surgical procedures;
• Presence of an active and uncontrolled periodontal disease;
• Bruxism;
• Smoking
• A history of local radiotherapy to the head and neck region.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dental implant and a screw-retained implant-supported zirconia restoration; patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration	Device: Astra Tech Osseospeed EV® dental implant; Prospective study of a group of 50 patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region.; Other Names: Atlantis™ CustomBase abutment with full-contour zirconia Atlantis® Crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peri-implant marginal bone level (in millimetres)	Difference in peri-implant bone level measured in millimetres	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival and restoration survival (in percentage)	Percentage of initially placed implants and restorations still in place after 5 years	5 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Henny Meijer, prof dr, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 18223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No