Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implants
• Intervention / Treatment: Device: Implant Treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Guillem Esteve-Pardo, PhD; Phone Number: +34965215755; Email: guillem@clinicaesteve.com

Study Locations

• Spain
  • Alicante, Spain, 03001
    • Recruiting
    • Clínica Dental Esteve
    • Contact: Guillem Esteve-Pardo, PhD; Phone Number: +34 965215755; Email: guillem@clinicaesteve.es
    • Principal Investigator: Guillem Esteve-Pardo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving DS Prime Taper dental implant in a private dental office.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• When dental implant surgery is contraindicated.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients DS Prime Taper; Patients who receive al least one DS Prime Taper on his dental implant treatment.	Device: Implant Treatment; Surgical placement of a DS Prime Taper implant and its posterior prosthesis.; Other Names: Implant surgery; Implant prosthesis; Implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival Rate	Time of survival of DS Prime Taper dental implant placed	through study completion, an average of 1 year
Implant Success Rate	Radiological assessment of Marginal Bone Levels around DS Prime Taper implants in function	through study completion, an average of 1 year
Biological and mechanical complications events	All type of complications that may occur during implant survival	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Aula Dental Avanzada
• Investigators: Principal Investigator: Guillem Esteve-Pardo, PhD, Clínica Dental Esteve

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Complication; Dental implant; DS Prime Taper
• Other Study ID Numbers: DSPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available on request from the corresponding author once publication is accomplished.
• IPD Sharing Time Frame: Once study completion date reached
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No