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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: Conometric Abutment and Conometric Final Cap

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Winnipeg, Canada
    • Cholakis Dental Group
• Germany
  • Ludwigshafen, Germany
    • Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
• Italy
  • Busto Arsizio, Italy
    • Studio Toia
• Spain
  • Cheste, Spain
    • Clínica Dental Broseta
  • Oviedo, Spain
    • Clinica Dental Antuña de Alaiz SL
• United Kingdom
  • London, United Kingdom
    • Ten Dental
  • Maidstone, United Kingdom
    • The Implant Experts LTD
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois College of Dentistry
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73142
      • Implant & Prosthodontic Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single tooth restorations using Acuris conometric concept	Device: Conometric Abutment and Conometric Final Cap; Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Marco Degidi, Dr., Degidi Dental Clinic, Bologna, Italy

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: C-OT-17-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes