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NCT Number: NCT04063878

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Jaw, Edentulous, Partially Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cholakis Dental Group, Winnipeg, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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)

Treatment and study plan

Conometric Abutment and Conometric Final Cap

Device

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

Primary outcomes

  1. Prosthetic Survival

    Time frame: 1 year after permanent restoration

    Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment. Prosthetic survival will be categorized as No/Yes. It will be categorized as "Yes" if all of the following criteria are fulfilled:

    • Permanent restoration is remaining in situ.
    • No loss of conometric retention between abutment and final cap.
    • No fracture of abutment.
    • No loss of abutment.

Secondary outcomes

  1. Prosthetic Survival

    Time frame: 3 and 5 years after permanent restoration

  2. Implant Survival

    Time frame: 1, 3 and 5 years after permanent restoration

  3. Marginal Bone Levels Alterations

    Time frame: 1, 3 and 5 years after permanent restoration

  4. Bleeding on Probing

    Time frame: 1, 3 and 5 years after permanent restoration

    Proportion of implants with any bleeding and proportion of bleeding surfaces

  5. Plaque

    Time frame: 1, 3 and 5 years after permanent restoration

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

  6. Probing Pocket Depth

    Time frame: 1, 3 and 5 years after permanent restoration

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

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2027
First posted
Aug 21, 2019
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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