Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

NCT ID: NCT05500755

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-29

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Dental Implants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients DS Prime Taper

Patients who receive al least one DS Prime Taper on his dental implant treatment.

Implant Treatment

Intervention Type DEVICE

Surgical placement of a DS Prime Taper implant and its posterior prosthesis.

Interventions

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Implant Treatment

Surgical placement of a DS Prime Taper implant and its posterior prosthesis.

Intervention Type DEVICE

Other Intervention Names

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Implant surgery Implant prosthesis Implant placement

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* When dental implant surgery is contraindicated.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aula Dental Avanzada

OTHER

Sponsor Role lead

Responsible Party

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Guillem Esteve-Pardo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillem Esteve-Pardo, PhD

Role: PRINCIPAL_INVESTIGATOR

Clínica Dental Esteve

Locations

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Clínica Dental esteve

Alicante, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Guillem Esteve-Pardo, PhD

Role: CONTACT

+34965215755

Facility Contacts

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Guillem Esteve-Pardo, PhD

Role: primary

+34 965215755

References

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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.

Reference Type BACKGROUND
PMID: 27447160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31591290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28834532 (View on PubMed)

Other Identifiers

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DSPT

Identifier Type: -

Identifier Source: org_study_id

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