Jaw, Edentulous, PartiallyNCT04063878
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
A study testing Conometric Abutment and Conometric Final Cap in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 9 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Conometric Abutment and Conometric Final Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 30 Jul 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United States2 sites
University of Illinois College of Dentistry
Chicago, Illinois, 60612
Implant & Prosthodontic Associates
Oklahoma City, Oklahoma, 73142
Spain2 sites
Clínica Dental Broseta
Cheste
Clinica Dental Antuña de Alaiz SL
Oviedo
United Kingdom2 sites
Ten Dental
London
The Implant Experts LTD
Maidstone
About this study
Official title: A Prospective, Multicenter Study on Acuris™ - Conometric Concept for Single Tooth Restoration. A 5-year Follow-up Study
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.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Conometric Abutment and Conometric Final Cap
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conometric Abutment and Conometric Final CapDevice
Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
| Study group | Role | What they receive |
|---|---|---|
| Single tooth restorations using Acuris conometric concept | Experimental | Not described Receives: Device: Conometric Abutment and Conometric Final Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after permanent restoration
Secondary outcomes (6)
Prosthetic Survival
Measured: 3 and 5 years after permanent restoration
Implant Survival
Measured: 1, 3 and 5 years after permanent restoration
Marginal Bone Levels Alterations
Measured: 1, 3 and 5 years after permanent restoration
Bleeding on Probing
Proportion of implants with any bleeding and proportion of bleeding surfaces
Measured: 1, 3 and 5 years after permanent restoration
Plaque
Proportion of implants with any plack and proportion of all four surfaces with any plaque
Measured: 1, 3 and 5 years after permanent restoration
Probing Pocket Depth
Measured aspects/side of implant; mean value, absolute value and changes.
Measured: 1, 3 and 5 years after permanent restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start30 Jul 2019
- Primary completion30 Sep 2023
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Degidi, Dr., Principal investigator, Degidi Dental Clinic, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063878
- Sponsor's protocol ID
- C-OT-17-003
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2019
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study on Acuris™ - Conometric Concept for Single Tooth Restoration. A 5-year Follow-up Study
- ClinicalTrials.gov ID
- NCT04063878
- Acronym / sponsor ID
- C-OT-17-003
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single tooth restorations using Acuris conometric concept | Experimental | Device: Conometric Abutment and Conometric Final Cap |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conometric Abutment and Conometric Final CapConometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive. | Device | Single tooth restorations using Acuris conometric concept |
Primary outcome
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.
6 secondary outcomes
Prosthetic Survival
Time frame: 3 and 5 years after permanent restoration
Implant Survival
Time frame: 1, 3 and 5 years after permanent restoration
Marginal Bone Levels Alterations
Time frame: 1, 3 and 5 years after permanent restoration
Bleeding on Probing
Time frame: 1, 3 and 5 years after permanent restoration
Plaque
Time frame: 1, 3 and 5 years after permanent restoration
Probing Pocket Depth
Time frame: 1, 3 and 5 years after permanent restoration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42616267Gehrke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Degidi, Dr. principal investigator
Degidi Dental Clinic, Bologna, Italy
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conometric Abutment and Conometric Final Cap in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain, United Kingdom, Canada, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Survival (time frame: 1 year after permanent restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.