A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Running, not enrolling · Not applicable
Conditions studied: Jaw, Edentulous, Partially
In brief
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.
Key facts
- Study ID
- NCT04063878
- Run by
- Dentsply Sirona Implants and Consumables
- People needed
- 160
- Starts
- 2019-07-30
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2025-08-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Illinois College of Dentistry — Chicago, Illinois, United States
- Implant & Prosthodontic Associates — Oklahoma City, Oklahoma, United States
- Cholakis Dental Group — Winnipeg, Canada
- Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH — Ludwigshafen, Germany
- Studio Toia — Busto Arsizio, Italy
- Clínica Dental Broseta — Cheste, Spain
- Clinica Dental Antuña de Alaiz SL — Oviedo, Spain
- Ten Dental — London, United Kingdom
- The Implant Experts LTD — Maidstone, United Kingdom
Full record on ClinicalTrials.gov
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