Trial Outcomes & Findings for A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration (NCT NCT04063878)

NCT ID: NCT04063878

Last Updated: 2025-08-24

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: 1 year after permanent restoration
• Results posted on: 2025-08-24

Participant Flow

Participant milestones

Measure	Single Tooth Restorations Using Acuris Conometric Concept Conometric Abutment and Conometric Final Cap: Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Overall Study STARTED	160
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Single Tooth Restorations Using Acuris Conometric Concept Conometric Abutment and Conometric Final Cap: Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Overall Study Withdrawal by Subject	2
Overall Study Subject not fulfilling study eligibility criteria	14

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Single Tooth Restorations Using Acuris Conometric Concept n=144 Participants Conometric Abutment and Conometric Final Cap: Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Age, Continuous	50.32 Years STANDARD_DEVIATION 12.46 • n=144 Participants
Sex: Female, Male Female	79 Participants n=144 Participants
Sex: Female, Male Male	65 Participants n=144 Participants

PRIMARY outcome

Timeframe: 1 year after permanent restoration

Population: Per protocol 144 - Visit data missing for 13 participants.

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.

Outcome measures

Measure	Single Tooth Restorations Using Acuris Conometric Concept n=131 Permanent restorations Conometric Abutment and Conometric Final Cap: Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Prosthetic Survival Prosthetic survival - Yes	127 Permanent restorations
Prosthetic Survival Prosthetic survival - No	4 Permanent restorations

SECONDARY outcome

Timeframe: 3 and 5 years after permanent restoration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 5 years after permanent restoration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 5 years after permanent restoration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 5 years after permanent restoration

Proportion of implants with any bleeding and proportion of bleeding surfaces

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 5 years after permanent restoration

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 5 years after permanent restoration

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

Outcome measures

Outcome data not reported

Adverse Events

Single Tooth Restorations Using Acuris Conometric Concept

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Tooth Restorations Using Acuris Conometric Concept n=160 participants at risk Conometric Abutment and Conometric Final Cap: Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Infections and infestations COVID-19	1.2% 2/160 • Number of events 2 • From enrollment up to1 year after permanent restoration.
Renal and urinary disorders Renal colic	0.62% 1/160 • Number of events 1 • From enrollment up to1 year after permanent restoration.
Renal and urinary disorders Hypotensive crisis and renal insufficiency	0.62% 1/160 • Number of events 1 • From enrollment up to1 year after permanent restoration.

Other adverse events

Measure	Single Tooth Restorations Using Acuris Conometric Concept n=160 participants at risk Conometric Abutment and Conometric Final Cap: Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Product Issues Loss of conometric retention between abutment and final cap	5.0% 8/160 • Number of events 8 • From enrollment up to1 year after permanent restoration.

Additional Information

Clinical Research Manager

Dentsply IH AB d.b.a Dentsply Sirona Implants

Phone: +46 31 376 44 11

Email: marie.ahlson@dentsplysirona.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60