Jaw, Edentulous, Partially
Conditions
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.
Interventions
DEVICEConometric Abutment and Conometric Final Cap
Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Survival | 3 and 5 years after permanent restoration | — |
| Implant Survival | 1, 3 and 5 years after permanent restoration | — |
| Marginal Bone Levels Alterations | 1, 3 and 5 years after permanent restoration | — |
| Bleeding on Probing | 1, 3 and 5 years after permanent restoration | Proportion of implants with any bleeding and proportion of bleeding surfaces |
| Plaque | 1, 3 and 5 years after permanent restoration | Proportion of implants with any plack and proportion of all four surfaces with any plaque |
| Probing Pocket Depth | 1, 3 and 5 years after permanent restoration | Measured aspects/side of implant; mean value, absolute value and changes. |
Countries
Canada, Germany, Italy, Spain, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMarco Degidi, Dr.
Degidi Dental Clinic, Bologna, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 144 |
| Total | 144 |
Baseline characteristics
| Characteristic | Single Tooth Restorations Using Acuris Conometric Concept |
|---|---|
| Age, Continuous | 50.32 Years STANDARD_DEVIATION 12.46 |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 160 |
| other Total, other adverse events | 8 / 160 |
| serious Total, serious adverse events | 4 / 160 |
Outcome results
Primary
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
Population: Per protocol 144 - Visit data missing for 13 participants.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Single Tooth Restorations Using Acuris Conometric Concept | Prosthetic Survival | Prosthetic survival - Yes | 127 Permanent restorations |
| Single Tooth Restorations Using Acuris Conometric Concept | Prosthetic Survival | Prosthetic survival - No | 4 Permanent restorations |
Secondary
Bleeding on Probing
Proportion of implants with any bleeding and proportion of bleeding surfaces
Time frame: 1, 3 and 5 years after permanent restoration
Secondary
Implant Survival
Time frame: 1, 3 and 5 years after permanent restoration
Secondary
Marginal Bone Levels Alterations
Time frame: 1, 3 and 5 years after permanent restoration
Secondary
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
Secondary
Probing Pocket Depth
Measured aspects/side of implant; mean value, absolute value and changes.
Time frame: 1, 3 and 5 years after permanent restoration
Secondary
Prosthetic Survival
Time frame: 3 and 5 years after permanent restoration