Menu
Recruiting NCT05500755

Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

— Observational Dental Implants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implant Treatment.
Who it may be relevant to
Registry conditions: Dental Implants. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants: A Prospective Medium Term Study

Overview

The DS Prime Taper EV dental implant system was recently launched on the implant market by Dentsply Sirona (York, PA, USA). Dental implant systems are undergoing rapid evolution, ultimately driven by their broad therapeutic indications. As manufacturers strive to keep up with the demands of a growing market, designs are changing faster than clinical evaluation. This means that the time needed to assess medium- and long-term clinical outcomes before designs change again cannot be met. Clinicians need to have a "real" analysis of the clinical performance of implants before using them. Therefore, reporting of results is necessary to avoid use in patients without proper practical checks even before the recommended 10- and 15-year follow-up periods.

Detailed description

The DS PrimeTaper implant has macro-design features that differ from its predecessor, the OsseoSpeed EV implant (AstraTech Implant System EV, Dentsply Implants, Mölndal, Sweden) with which they share a common surface and internal connection.

Its macro-design has been modified through the introduction of variable thread forms and a more pronounced taper, ultimately making it more aggressive in terms of cutting ability.

While its predecessor, the OsseoSpeed EV implant, has sufficient scientific support, this new system recently introduced on the market does not. All the scientific contributions that can be made will therefore be a first guide for the clinician who wishes to start using this dental implant system.

Interventions

  • Device Implant Treatment
    Surgical placement of a DS Prime Taper implant and its posterior prosthesis.

Primary outcome measures

  • Implant Survival Rate [Time frame: through study completion, an average of 1 year]
  • Implant Success Rate [Time frame: through study completion, an average of 1 year]
  • Biological and mechanical complications events [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • All the patients whom received at least one DS Prime Taper implant.

Exclusion criteria

  • When dental implant surgery is contraindicated.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Clínica Dental esteve — Alicante

Publications

  • Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869. PMID 27447160
  • Choi NH, Yoon HI, Kim TH, Park EJ. Improvement in Fatigue Behavior of Dental Implant Fixtures by Changing Internal Connection Design: An In Vitro Pilot Study. Materials (Basel). 2019 Oct 7;12(19):3264. doi: 10.3390/ma12193264. PMID 31591290
  • Toia M, Galli S, Cecchinato D, Wennerberg A, Jimbo R. Clinical Evidence of OsseoSpeed EV Implants: A Retrospective Study and Characterization of the Newly Introduced System. Int J Periodontics Restorative Dent. 2019 November/December;39(6):863-874. doi: 10.11607/prd.2549. Epub 2017 Aug 23. PMID 28834532

Identifiers

NCT: NCT05500755 · DSPT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗