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

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04063878
• Other study ID #: C-OT-17-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Dentsply Sirona Implants and Consumables
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 30, 2027
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• Conometric Abutment and Conometric Final Cap
Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.

Locations

Country	Name	City	State
Canada	Cholakis Dental Group	Winnipeg
Germany	Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH	Ludwigshafen
Italy	Studio Toia	Busto Arsizio
Spain	Clínica Dental Broseta	Cheste
Spain	Clinica Dental Antuña de Alaiz SL	Oviedo
United Kingdom	Ten Dental	London
United Kingdom	The Implant Experts LTD	Maidstone
United States	University of Illinois College of Dentistry	Chicago	Illinois
United States	Implant & Prosthodontic Associates	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants and Consumables

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic survival	Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment	1 year after permanent restoration
Secondary	Prosthetic survival		3 and 5 years after permanent restoration
Secondary	Implant survival		1, 3 and 5 years after permanent restoration
Secondary	Marginal Bone Levels alterations		1, 3 and 5 years after permanent restoration
Secondary	Bleeding on Probing	Proportion of implants with any bleeding and proportion of bleeding surfaces	1, 3 and 5 years after permanent restoration
Secondary	Plaque	Proportion of implants with any plack and proportion of all four surfaces with any plaque	1, 3 and 5 years after permanent restoration
Secondary	Probing Pocket Depth	Measured aspects/side of implant; mean value, absolute value and changes.	1, 3 and 5 years after permanent restoration