Clinical trial NCT05500755: Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Official title: Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants: A Prospective Medium Term Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Implants
Keywords: Dental implant
Complication
DS Prime Taper
Lead sponsor: Aula Dental Avanzada
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving DS Prime Taper dental implant in a private dental office.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* When dental implant surgery is contraindicated.

Primary outcomes:
measure: Implant Survival Rate
timeFrame: through study completion, an average of 1 year
measure: Implant Success Rate
timeFrame: through study completion, an average of 1 year
measure: Biological and mechanical complications events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Clínica Dental esteve
Study officials:
affiliation: Clínica Dental Esteve
name: Guillem Esteve-Pardo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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):906-15. doi: 10.11607/jomi.4869.
citation: 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.
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: 10.11607/prd.2549. Epub 2017 Aug 23.