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

Study Overview
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Brief Summary
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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.

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

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Conometric Abutment and Conometric Final Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject aged between 18-75 years Subject signed and dated the informed consent form 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. 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. Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown Deemed by the investigator as likely to present an initially stable implant situation Exclusion Criteria: Unlikely to be able to comply with study procedures, according to Investigators judgement Subject is not willing to participate in the study or not able to understand the content of the study Involvement in the planning and conduct of the study Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants. Unable or unwilling to return for follow-up visits for a period of five years 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 Previous enrolment in the present study Uncontrolled pathological process in the oral cavity Known or suspected current malignancy History of radiation therapy in the head and neck region within 12 months prior to surgery Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration Uncontrolled diabetes mellitus Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration Current need for major bone grafting and/or augmentation in the planned implant area (minor grafting and soft tissue grafting are allowed) Present alcohol and drug abuse Smoking more than 10 cigarettes per day Exclusion criteria at Visit 5 (Permanent Restoration) Permanent restoration delivered later than 6 months after implant placement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |