A Prospective, Multicenter Study on Acuris™ - Conometric Concept for Single Tooth Restoration. A 5-year Follow-up Study

Dentsply Sirona Implants and Consumables9 sites in 6 countries160 target enrollmentJuly 30, 2019

ConditionsJaw, Edentulous, Partially

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jaw, Edentulous, Partially
Sponsor: Dentsply Sirona Implants and Consumables
Enrollment: 160
Locations: 9
Primary Endpoint: Prosthetic Survival
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.

Registry

clinicaltrials.gov

Start Date

July 30, 2019

End Date

June 30, 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dentsply Sirona Implants and Consumables

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject aged between 18-75 years
•Subject signed and dated the informed consent form
•In need of an implant replacing a missing tooth in position 17 to 27 or 37 to 47, and each subject can only receive one study implant.
•Neighbouring tooth to the planned implant must have
•a natural root or an implant supported restoration mesially
•a natural root or an implant supported restoration distally Exemption: If the planned implant is in the second molar position, an edentulous space is accepted distally.
•Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown
•Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria

•Unlikely to be able to comply with study procedures, according to Investigators judgement
•Subject is not willing to participate in the study or not able to understand the content of the study
•Involvement in the planning and conduct of the study
•Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
•Unable or unwilling to return for follow-up visits for a period of five years
•Simultaneous participation in another clinical study, or former participation in a clinical study during the last 6 months that may interfere with the present study
•Previous enrolment in the present study
•Uncontrolled pathological process in the oral cavity
•Known or suspected current malignancy
•History of radiation therapy in the head and neck region within 12 months prior to surgery

Outcomes

Primary Outcomes

Prosthetic Survival

Time Frame: 1 year after permanent restoration

Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment. Prosthetic survival will be categorized as No/Yes. It will be categorized as "Yes" if all of the following criteria are fulfilled: * Permanent restoration is remaining in situ. * No loss of conometric retention between abutment and final cap. * No fracture of abutment. * No loss of abutment.