Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single tooth restorations using Acuris conometric concept | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conometric Abutment and Conometric Final Cap | Device | Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 year after permanent restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Survival | 3 and 5 years after permanent restoration | |
| Implant Survival | 1, 3 and 5 years after permanent restoration | |
| Marginal Bone Levels Alterations |
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marco Degidi, Dr. | Degidi Dental Clinic, Bologna, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois College of Dentistry | Chicago | Illinois | 60612 | United States | ||
| Implant & Prosthodontic Associates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1, 3 and 5 years after permanent restoration |
| Bleeding on Probing | Proportion of implants with any bleeding and proportion of bleeding surfaces | 1, 3 and 5 years after permanent restoration |
| Plaque | Proportion of implants with any plack and proportion of all four surfaces with any plaque | 1, 3 and 5 years after permanent restoration |
| Probing Pocket Depth | Measured aspects/side of implant; mean value, absolute value and changes. | 1, 3 and 5 years after permanent restoration |
| 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 |
| COMPLETED | 1 year after permanent restoration |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Per protocol 144 - Visit data missing for 13 participants. | Posted | Count of Units | Permanent restorations | 1 year after permanent restoration | Permanent restorations | Permanent restorations |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Prosthetic Survival | Not Posted | 3 and 5 years after permanent restoration | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Implant Survival | Not Posted | 1, 3 and 5 years after permanent restoration | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Marginal Bone Levels Alterations | Not Posted | 1, 3 and 5 years after permanent restoration | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Bleeding on Probing | Proportion of implants with any bleeding and proportion of bleeding surfaces | Not Posted | 1, 3 and 5 years after permanent restoration | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Plaque | Proportion of implants with any plack and proportion of all four surfaces with any plaque | Not Posted | 1, 3 and 5 years after permanent restoration | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Probing Pocket Depth | Measured aspects/side of implant; mean value, absolute value and changes. | Not Posted | 1, 3 and 5 years after permanent restoration | Participants |
From enrollment up to1 year after permanent restoration.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 160 | 4 | 160 | 8 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Renal colic | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypotensive crisis and renal insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of conometric retention between abutment and final cap | Product Issues | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Dentsply IH AB d.b.a Dentsply Sirona Implants | +46 31 376 44 11 | marie.ahlson@dentsplysirona.com |
| Jan 15, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided