CClinicalTrials.gg
Active, not recruitingNCT04063878Updated Sep 18, 2026Results posted

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

An interventional study of Conometric Abutment and Conometric Final Cap in Jaw, Edentulous, Partially, sponsored by Dentsply Sirona Implants and Consumables. Active, not recruiting at 9 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Dentsply Sirona Implants and Consumables · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Jaw, Edentulous, Partially
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In context

Jaw, Edentulous, Partially

66 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.

This study's enrollment of 160 is above the median of 36 across 58 interventional studies indexed under Jaw, Edentulous, Partially.

Browse Jaw, Edentulous, Partially studies →

Lead sponsor

Dentsply Sirona Implants and Consumables is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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. Smoking more than 10 cigarettes per day, present alcohol or drug abuse
  16. Known pregnancy at implant installation (Only applicable for sites in United States and Canada)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Single tooth restorations using Acuris conometric concept

    Device: Conometric Abutment and Conometric Final Cap

Interventions

  • DeviceConometric Abutment and Conometric Final Cap

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

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What researchers measure

Primary outcomes

  1. Prosthetic Survival

    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.

    Time frame: 1 year after permanent restoration

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

    Proportion of implants with any bleeding and proportion of bleeding surfaces

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

  5. Plaque

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

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

  6. Probing Pocket Depth

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

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

07

Results

Posted Mar 5, 2025

Participant flow

Participant flow — Overall Study
MilestoneSingle Tooth Restorations Using Acuris Conometric Concept
Started160
Completed144
Not completed16
Withdrew: Withdrawal by subject2
Withdrew: Subject not fulfilling study eligibility criteria14

Outcome measures

PrimaryProsthetic Survival

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.

Time frame:
1 year after permanent restoration
Reported as:
Count of units · Permanent restorations
Prosthetic Survival
Permanent restorationsSingle Tooth Restorations Using Acuris Conometric Concept
Prosthetic survival - Yes127
Prosthetic survival - No4
SecondaryProsthetic Survival
Time frame:
3 and 5 years after permanent restoration

Results for this outcome have not been posted.

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

Results for this outcome have not been posted.

SecondaryMarginal Bone Levels Alterations
Time frame:
1, 3 and 5 years after permanent restoration

Results for this outcome have not been posted.

SecondaryBleeding on Probing

Proportion of implants with any bleeding and proportion of bleeding surfaces

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

Results for this outcome have not been posted.

SecondaryPlaque

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

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

Results for this outcome have not been posted.

SecondaryProbing Pocket Depth

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

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

Results for this outcome have not been posted.

Adverse events

Collected over From enrollment up to1 year after permanent restoration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single Tooth Restorations Using Acuris Conometric Concept0/160 (0%)4/160 (2.5%)8/160 (5%)
Most frequent serious events
Most frequent serious events
EventSingle Tooth Restorations Using Acuris Conometric Concept
COVID-19Infections and infestations2/160
Renal colicRenal and urinary disorders1/160
Hypotensive crisis and renal insufficiencyRenal and urinary disorders1/160
Most frequent other events
Most frequent other events
EventSingle Tooth Restorations Using Acuris Conometric Concept
Loss of conometric retention between abutment and final capProduct Issues8/160

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Single Tooth Restorations Using Acuris Conometric Concept
Mean50.32 ± 12.46
Sex: Female, Male
Sex: Female, Male(Participants)Single Tooth Restorations Using Acuris Conometric Concept
Female79
Male65
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Single Tooth Restorations Using Acuris Conometric Concept
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Study locations

9 sites
  • University of Illinois College of Dentistry
    Chicago, Illinois 60612, United States
  • Implant & Prosthodontic Associates
    Oklahoma City, Oklahoma 73142, 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
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References and documents

Publications

  • Gehrke P, Weinhold O, Antuna P, Bendkowski A, Broseta ML, Cholakis E, Cooper L, McGarry TJ, Wanendeya M, Kreis J, Toia M. Clinical performance of a conometric retention system for single implant restorations: 1-year analysis of a prospective multicenter study. Int J Implant Dent. 2026 Aug 19;12(1):41. doi: 10.1186/s40729-026-00708-z. PubMed 42616267 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04063878
Lead sponsor
Dentsply Sirona Implants and Consumables
Responsible party
Sponsor
First posted
Aug 21, 2019
Start date
Jul 30, 2019
Primary completion
Sep 30, 2023
Completion
Jun 30, 2027 (estimated)
Results posted
Mar 5, 2025
Last update
Sep 18, 2026

Study contacts

Marco Degidi, Dr.
principal investigator · Degidi Dental Clinic, Bologna, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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