A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration

Dentsply

Status: Active, not recruiting

Conditions: Jaw, Edentulous, Partially

Treatments: Device: Conometric Abutment and Conometric Final Cap

Study type: Interventional

Funder types: Industry

Identifiers

NCT04063878

C-OT-17-003

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject aged between 18-75 years

2. Subject signed and dated the informed consent form

3. 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.

4. 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.

5. Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown

6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria

1. Unlikely to be able to comply with study procedures, according to Investigators judgement
2. Subject is not willing to participate in the study or not able to understand the content of the study
3. Involvement in the planning and conduct of the study
4. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
5. Unable or unwilling to return for follow-up visits for a period of five years
6. 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
7. Previous enrolment in the present study
8. Uncontrolled pathological process in the oral cavity
9. Known or suspected current malignancy
10. History of radiation therapy in the head and neck region within 12 months prior to surgery
11. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
12. Uncontrolled diabetes mellitus
13. Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
14. Current need for major bone grafting and/or augmentation in the planned implant area (minor grafting and soft tissue grafting are allowed)
15. Smoking more than 10 cigarettes per day, present alcohol or drug abuse
16. Known pregnancy at implant installation (Only applicable for sites in United States and Canada)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Single tooth restorations using Acuris conometric concept

Experimental group

Treatment:

Device: Conometric Abutment and Conometric Final Cap