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

Not Applicable

Active, not recruiting

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: Conometric Abutment and Conometric Final Cap

• 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
• Last Update Submitted: 2025-02-11
• Results First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• 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. Present alcohol and drug abuse

16. Smoking more than 10 cigarettes per day

    Exclusion criteria at Visit 5 (Permanent Restoration)

17. Permanent restoration delivered later than 6 months after implant placement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single tooth restorations using Acuris conometric concept	Conometric Abutment and Conometric Final Cap	-

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)

Studio Toia; 🇮🇹 Busto Arsizio, Italy

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

Ten Dental; 🇬🇧 London, United Kingdom

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

The Implant Experts LTD; 🇬🇧 Maidstone, United Kingdom

Cholakis Dental Group; 🇨🇦 Winnipeg, Canada

Clínica Dental Broseta; 🇪🇸 Cheste, Spain

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

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