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

Primary Purpose

Jaw, Edentulous, Partially

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Conometric Abutment and Conometric Final Cap

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single tooth restorations using Acuris conometric concept

Arm Description

Outcomes

Primary Outcome Measures

Prosthetic survival

Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment

Secondary Outcome Measures

Prosthetic survival

Implant survival

Marginal Bone Levels alterations

Bleeding on Probing

Proportion of implants with any bleeding and proportion of bleeding surfaces

Plaque

Proportion of implants with any plack and proportion of all four surfaces with any plaque

Probing Pocket Depth

Measured aspects/side of implant; mean value, absolute value and changes.

Full Information

NCT ID

NCT04063878

First Posted

August 15, 2019

Last Updated

December 2, 2022

Sponsor

Dentsply Sirona Implants and Consumables

1. Study Identification

Unique Protocol Identification Number

NCT04063878

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 30, 2019 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dentsply Sirona Implants and Consumables

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw, Edentulous, Partially

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single tooth restorations using Acuris conometric concept

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Conometric Abutment and Conometric Final Cap

Intervention Description

Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.

Primary Outcome Measure Information:

Title

Prosthetic survival

Description

Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment

Time Frame

1 year after permanent restoration

Secondary Outcome Measure Information:

Title

Prosthetic survival

Time Frame

3 and 5 years after permanent restoration

Title

Implant survival

Time Frame