Status:
ACTIVE_NOT_RECRUITING
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Jaw, Edentulous, Partially
Eligibility:
All Genders
18-75 years
Phase:
NA
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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)
- Smoking more than 10 cigarettes per day, present alcohol or drug abuse
- Known pregnancy at implant installation (Only applicable for sites in United States and Canada)
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04063878
Start Date
July 30 2019
End Date
June 30 2027
Last Update
August 24 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Illinois College of Dentistry
Chicago, Illinois, United States, 60612
2
Implant & Prosthodontic Associates
Oklahoma City, Oklahoma, United States, 73142
3
Cholakis Dental Group
Winnipeg, Canada
4
Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
Ludwigshafen, Germany