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Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. The primary objective was to evaluate implant survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Experimental | ANKYLOS C/X Implant A 6.6 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANKYLOS C/X implant A 6.6 | Device | Treatment with six (6) 6.6 mm implants and a bridge to restore chewing function of an edentulous maxilla. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | Any implant that is removed after implant placement will be considered failure, whatever reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. | At Visit 14, 5 years after permanent restoration (PR). |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability | Implant stability was evaluated clinically/manually by the investigator at implant placement visit (this initial manual check is called primary stability), and again at the abutment surgery visit. The stability evaluation was recorded as yes/no, yes = judged by the investigator to be stable, or no = judged by the investigator to be unstable. Stability was assessed at implant placement (IP) (Visit 3), and at Abutment Surgery and Impression (Visit 5, at 13 weeks after IP). |
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INCLUSION CRITERIA
For inclusion in the study subjects had to meet all of the following criteria:
Aged 18-80 years at inclusion.
Signed informed consent.
In need of full-arch restoration of the maxilla.
The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
Maxilla: totally edentulous, fulfilling all of the following criteria:
Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw.
EXCLUSION CRITERIA
Any of the following was regarded as a criterion for exclusion from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Weigl | J. W. Goethe-Universität, Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Southeastern University | Fort Lauderdale | Florida | 33328 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ANKYLOS C/X Implant A 6.6 | Subjects treated with ANKYLOS C/X Implant A 6.6 mm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
12 subjects received implants in the clinical investigation.
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| ID | Title | Description |
|---|---|---|
| BG000 | ANKYLOS C/X Implant A 6.6 | Subjects treated with ANKYLOS C/X Implant A 6.6 mm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Implant Survival Rate | Any implant that is removed after implant placement will be considered failure, whatever reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. | Intention to treat. | Posted | Count of Units | Implants | At Visit 14, 5 years after permanent restoration (PR). | Implants | Implants |
|
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On average 5.5 years. Adverse event data were collected from enrollment (signing informed consent) up to study termination (Visit 14, 5 years after PR).
Safety endpoints were Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE) and Device Deficiencies (DD)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANKYLOS C/X Implant A 6.6 | Subjects treated with ANKYLOS C/X Implant A 6.6 mm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental implant related event | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulrika Bonander | DENTSPLY IH AB, | 31 376 30 68 | +46 | ulrika.bonander@dentsplysirona.com |
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| 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 5, 2015 | Jan 16, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP). |
| Mean Marginal Bone Level (MBL) at Subject's Tissue Level | The mean Marginal Bone Level (MBL) on subject level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. The reference point is defined as the implant shoulder. | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| Mean Marginal Bone Level (MBL) on Implant Level. | The mean Marginal Bone Level (MBL) on implant level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. The reference point is defined as the implant shoulder. | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| Mean Probing Pocket Depth (PPD) at Subject Level. | PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| At Least One Surface With Plaque. | Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually). | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| Any Bleeding on Implant (BoP) | BoP was evaluated at each of the four surfaces around the implant site (mesially, distally, buccally and lingually), by using a periodontal probe. BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket. | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| Oral Health Impact Profile 14 (OHIP-14) | Patient satisfaction was evaluated using the Oral Health Impact Profile 14 (OHIP-14). The questionnaire was filled in by the subjects before and after treatment with implants. OHIP-14 includes seven domains: functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. An example of an OHIP statement is "Have you had to interrupt meals because of problems with your teeth, mouth or dentures". Responses are based on a Likert scale (i.e., 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The lowest possible total score (all question responses summed) of the OHIP-4 questionnaire is 0, and the highest possible score is 56. A high score is linked to a poor outcome. | At pre-surgical planning (Visit 2) on average 6 months before PR, and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| Prosthetic Survival Rate on Subject Level | A prosthetic restoration was considered a survived if the original restoration was still in place, regardless of its condition, at the follow-up visit. | At 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Implants |
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| Secondary | Implant Stability | Implant stability was evaluated clinically/manually by the investigator at implant placement visit (this initial manual check is called primary stability), and again at the abutment surgery visit. The stability evaluation was recorded as yes/no, yes = judged by the investigator to be stable, or no = judged by the investigator to be unstable. Stability was assessed at implant placement (IP) (Visit 3), and at Abutment Surgery and Impression (Visit 5, at 13 weeks after IP). | Intention to treat | Posted | Count of Units | Implants | At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP). | Implants | Implants |
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| Secondary | Mean Marginal Bone Level (MBL) at Subject's Tissue Level | The mean Marginal Bone Level (MBL) on subject level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. The reference point is defined as the implant shoulder. | Intention to treat | Posted | Mean | Standard Deviation | millimeters (mm) | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
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| Secondary | Mean Marginal Bone Level (MBL) on Implant Level. | The mean Marginal Bone Level (MBL) on implant level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. The reference point is defined as the implant shoulder. | Intention to treat group. 2 implants missing from the analysis at Visit 14 (5-year follow-up). | Posted | Mean | Standard Deviation | millimeters (mm) | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). | implants | implants |
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| Secondary | Mean Probing Pocket Depth (PPD) at Subject Level. | PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. | Intention to treat | Posted | Mean | Standard Deviation | millimeter (mm) | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
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| Secondary | At Least One Surface With Plaque. | Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually). | Intention to treat | Posted | Count of Units | implants | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). | implants | implants |
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| Secondary | Any Bleeding on Implant (BoP) | BoP was evaluated at each of the four surfaces around the implant site (mesially, distally, buccally and lingually), by using a periodontal probe. BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket. | Intention to treat | Posted | Count of Units | implants | At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). | implants | implants |
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| Secondary | Oral Health Impact Profile 14 (OHIP-14) | Patient satisfaction was evaluated using the Oral Health Impact Profile 14 (OHIP-14). The questionnaire was filled in by the subjects before and after treatment with implants. OHIP-14 includes seven domains: functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. An example of an OHIP statement is "Have you had to interrupt meals because of problems with your teeth, mouth or dentures". Responses are based on a Likert scale (i.e., 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The lowest possible total score (all question responses summed) of the OHIP-4 questionnaire is 0, and the highest possible score is 56. A high score is linked to a poor outcome. | Intention to treat | Posted | Mean | Standard Deviation | units on a scale | At pre-surgical planning (Visit 2) on average 6 months before PR, and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). |
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| Secondary | Prosthetic Survival Rate on Subject Level | A prosthetic restoration was considered a survived if the original restoration was still in place, regardless of its condition, at the follow-up visit. | Intention to treat | Posted | Count of Units | Prosthesis (Bridges) | At 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14). | Prosthesis (Bridges) | Prosthesis (Bridges) |
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| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| Dental abutment related event | Product Issues | Systematic Assessment |
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| Dental prosthesis related event | Product Issues | Systematic Assessment |
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| Porcelain chipping | Product Issues | Systematic Assessment |
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| Peri-implant tissue related event | Investigations | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Hand infection | Infections and infestations | Systematic Assessment |
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| Back injury and spinal fusion surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nickel allergy | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Muscle spasm neck region | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar vertebrae surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Yes |
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| 3-years post permanent restoration (Visit 12) |
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| 5-years post permanent restoration (Visit 14) |
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| 1-year post permanent restoration (Visit 10) |
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| 3-years post permanent restoration (Visit 12) |
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| 5-years post permanent restoration (Visit 14) |
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| 1-year post permanent restoration (Visit 10) |
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| 2-years post permanent restoration (Visit 11) |
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| 3-years post permanent restoration (Visit 12) |
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| 5-years post permanent restoration (Visit 14) |
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| Any plaque at 6-months post permanent restoration (Visit 9) |
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| Any plaque at 1-year post permanent restoration (Visit 10) |
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| Any plaque at 2-years post permanent restoration (Visit 11) |
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| Any plaque at 3-years post permanent restoration (Visit 12) |
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| Any plaque at 5-years post permanent restoration (Visit 14) |
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| Any surface with BoP at 6-months post permanent restoration (Visit 9) |
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| Any surface with BoP at 1-year post permanent restoration (Visit 10) |
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| Any surface with BoP at 2-years post permanent restoration (Visit 11) |
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| Any surface with BoP at 3-years post permanent restoration (Visit 12) |
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| Any surface with BoP at 5-years post permanent restoration (Visit 14) |
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| Overall (Q1-14) at 1-year post permanent restoration |
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| Overall (Q1-14) at 2-years post permanent restoration |
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| Overall (Q1-14) at 5-years post permanent restoration |
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| Original prosthesis not in place |
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| At 2-years post permanent restoration |
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| At 3-years post permanent restoration |
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| At 5-years post permanent restoration |
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