Clinical trial NCT04063878: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prosthetic Survival
timeFrame: 1 year after permanent restoration
Secondary outcomes:
measure: Prosthetic Survival
timeFrame: 3 and 5 years after permanent restoration
measure: Implant Survival
timeFrame: 1, 3 and 5 years after permanent restoration
measure: Marginal Bone Levels Alterations
timeFrame: 1, 3 and 5 years after permanent restoration
measure: Bleeding on Probing
timeFrame: 1, 3 and 5 years after permanent restoration
measure: Plaque
timeFrame: 1, 3 and 5 years after permanent restoration
measure: Probing Pocket Depth
timeFrame: 1, 3 and 5 years after permanent restoration
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois College of Dentistry
state: Illinois
city: Oklahoma City
country: United States
facility: Implant & Prosthodontic Associates
state: Oklahoma
city: Winnipeg
country: Canada
facility: Cholakis Dental Group
city: Ludwigshafen
country: Germany
facility: Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
city: Busto Arsizio
country: Italy
facility: Studio Toia
city: Cheste
country: Spain
facility: Clínica Dental Broseta
city: Oviedo
country: Spain
facility: Clinica Dental Antuña de Alaiz SL
city: London
country: United Kingdom
facility: Ten Dental
city: Maidstone
country: United Kingdom
facility: The Implant Experts LTD
Study officials:
affiliation: Degidi Dental Clinic, Bologna, Italy
name: Marco Degidi, Dr.
role: PRINCIPAL_INVESTIGATOR
References: