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Enrolling by Invitation

NCT Number: NCT06110611

Monolithic Zirconia With CAD/CAM Titanium Abutments: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713AV, Netherlands

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Atlantis™ CustomBase abutment with full-contour zirconia Atlantis® Crown

Primary outcomes

  1. Change in peri-implant marginal bone level (in millimetres)

    Time frame: 5 years

    Difference in peri-implant bone level measured in millimetres

Secondary outcomes

  1. Implant survival and restoration survival (in percentage)

    Time frame: 5 years

    Percentage of initially placed implants and restorations still in place after 5 years

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 31, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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