Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

NCT05500755 | Recruiting

• 1 other identifier: DSPT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants

Keywords

Dental implant; Complication; DS Prime Taper

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients DS Prime Taper

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

Device: Implant Treatment

Interventions

Implant Treatment DEVICE

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

Also known as: Implant surgery, Implant prosthesis, Implant placement

Patients DS Prime Taper

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• When dental implant surgery is contraindicated.

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (1)

Clínica Dental esteve

Alicante, Alicante, 03001, Spain

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Guillem Esteve-Pardo, PhD

  Clínica Dental Esteve

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillem Esteve-Pardo, PhD

CONTACT

+34965215755; guillem@clinicaesteve.com

Study Design

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

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: July 29, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Once study completion date reached

Locations

ES (1)