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

Not Applicable

Active, not recruiting

• Conditions: Jaw, Edentulous, Partially

• Registration Number: NCT04063878
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-30
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Primary Completion: 2023-09-30
• Results First Submitted: 2025-01-15
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-11
• Results First Posted: 2025-03-05
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-24
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prosthetic Survival	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.

Secondary Outcome Measures

Name	Time	Method
Implant Survival	1, 3 and 5 years after permanent restoration
Prosthetic Survival	3 and 5 years after permanent restoration
Bleeding on Probing	1, 3 and 5 years after permanent restoration	Proportion of implants with any bleeding and proportion of bleeding surfaces
Marginal Bone Levels Alterations	1, 3 and 5 years after permanent restoration
Plaque	1, 3 and 5 years after permanent restoration	Proportion of implants with any plack and proportion of all four surfaces with any plaque
Probing Pocket Depth	1, 3 and 5 years after permanent restoration	Measured aspects/side of implant; mean value, absolute value and changes.

Trial Locations

Locations (9)

University of Illinois College of Dentistry; 🇺🇸 Chicago, Illinois, United States

Implant & Prosthodontic Associates; 🇺🇸 Oklahoma City, Oklahoma, United States

Cholakis Dental Group; 🇨🇦 Winnipeg, Canada

Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH; 🇩🇪 Ludwigshafen, Germany

Studio Toia; 🇮🇹 Busto Arsizio, Italy

Clínica Dental Broseta; 🇪🇸 Cheste, Spain

Clinica Dental Antuña de Alaiz SL; 🇪🇸 Oviedo, Spain

Ten Dental; 🇬🇧 London, United Kingdom

The Implant Experts LTD; 🇬🇧 Maidstone, United Kingdom