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

NCT06110611 | Enrolling By Invitation

• 1 other identifier: 18223
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant marginal bone level (in millimetres)

  Difference in peri-implant bone level measured in millimetres

  5 years

Secondary Outcomes (1)

• Implant survival and restoration survival (in percentage)

  5 years

Study Arms (1)

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

Interventions

Astra Tech Osseospeed EV® dental implant DEVICE

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.

Also known as: Atlantis™ CustomBase abutment with full-contour zirconia Atlantis® Crown

dental implant and a screw-retained implant-supported zirconia restoration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713AV, Netherlands

Location

Study Officials

• Henny Meijer, prof dr

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof dr

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 31, 2023
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)