Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants

Recruiting

• Conditions: Dental Implants
• Interventions: Device: Implant Treatment

• Registration Number: NCT05500755
• Lead Sponsor: Aula Dental Avanzada

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.

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 Timeline

• Study Start: 2022-07-29
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• When dental implant surgery is contraindicated.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients DS Prime Taper	Implant Treatment	Patients who receive al least one DS Prime Taper on his dental implant treatment.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clínica Dental esteve; 🇪🇸 Alicante, Spain