Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500755
• Other study ID #: DSPT
• Status: Recruiting
• Start date: July 29, 2022
• Est. completion date: September 2, 2025

Study information

• Verified date: January 2024
• Source: Aula Dental Avanzada
• Contact: Guillem Esteve-Pardo, PhD
• Phone: +34965215755
• Email: guillem[@]clinicaesteve.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2, 2025
• Est. primary completion date: September 1, 2025
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• When dental implant surgery is contraindicated.

Related Conditions & MeSH terms

• Dental Implants

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Dental esteve	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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 — View Citation

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: 1 — View Citation

Outcome

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