Edentulous Maxilla
Conditions
Keywords
ANKYLOS, Simplant, maxilla, edentulous, short implants
Brief summary
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.
Detailed description
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.
Interventions
DEVICEANKYLOS C/X implant A 6.6
Treatment with six (6) 6.6 mm implants and a bridge to restore chewing function of an edentulous maxilla.
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 80 Years
Healthy volunteers
No
Inclusion criteria
For inclusion in the study subjects had to meet all of the following criteria: 1. Aged 18-80 years at inclusion. 2. Signed informed consent. 3. 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): 4. Maxilla: totally edentulous, fulfilling all of the following criteria: 1. History of edentulism: ≥ 6 months and, 2. Minimum bone height: ≥ 7 mm and, 3. Minimum bone width: ≥ 5.5 mm. 5. 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: 1. Unlikely to be able to comply with study procedures according to Investigator's judgement. 2. History of bone augmentation in the maxilla within 6 months prior to surgery. 3. Uncontrolled pathologic processes in the oral cavity. 4. Bruxism. 5. Smoking \>10 cigarettes per day. 6. Present alcohol or drug abuse. 7. History of radiation therapy in head and neck region. 8. History of chemotherapy within 5 years prior to surgery. 9. Condition that would compromise post-operative tissue healing or osseointegration. 10. Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration. 11. Known pregnancy at time of inclusion. 12. Current or former participation in a clinical study that may interfere with the present study. 13. Involvement in the planning and conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rate | At Visit 14, 5 years after permanent restoration (PR). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Marginal Bone Level (MBL) at Subject's Tissue Level | 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). | 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. |
| Mean Marginal Bone Level (MBL) on Implant Level. | 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). | 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. |
| Mean Probing Pocket Depth (PPD) at Subject Level. | 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). | PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. |
| Implant Stability | At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP). | 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). |
| Any Bleeding on Implant (BoP) | 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). | 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. |
| Oral Health Impact Profile 14 (OHIP-14) | 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). | 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. |
| Prosthetic Survival Rate on Subject Level | 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). | 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 Least One Surface With Plaque. | 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). | Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ANKYLOS C/X Implant A 6.6 Subjects treated with ANKYLOS C/X Implant A 6.6 mm. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | ANKYLOS C/X Implant A 6.6 | — |
|---|---|---|
| Age, Continuous | 60.2 Years STANDARD_DEVIATION 12.19 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: At Visit 14, 5 years after permanent restoration (PR).
Population: Intention to treat.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Implant Survival Rate | Implants confirmed as survived | 41 Implants |
| ANKYLOS C/X Implant A 6.6 | Implant Survival Rate | Implants confirmed to be failures | 19 Implants |
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.
Time frame: 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).
Population: Intention to treat
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Any Bleeding on Implant (BoP) | Any surface with BoP at permanent restoration (Visit 8) | 24 implants |
| ANKYLOS C/X Implant A 6.6 | Any Bleeding on Implant (BoP) | Any surface with BoP at 6-months post permanent restoration (Visit 9) | 44 implants |
| ANKYLOS C/X Implant A 6.6 | Any Bleeding on Implant (BoP) | Any surface with BoP at 1-year post permanent restoration (Visit 10) | 39 implants |
| ANKYLOS C/X Implant A 6.6 | Any Bleeding on Implant (BoP) | Any surface with BoP at 2-years post permanent restoration (Visit 11) | 29 implants |
| ANKYLOS C/X Implant A 6.6 | Any Bleeding on Implant (BoP) | Any surface with BoP at 3-years post permanent restoration (Visit 12) | 29 implants |
| ANKYLOS C/X Implant A 6.6 | Any Bleeding on Implant (BoP) | Any surface with BoP at 5-years post permanent restoration (Visit 14) | 15 implants |
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).
Time frame: 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).
Population: Intention to treat
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | At Least One Surface With Plaque. | Any plaque at 3-years post permanent restoration (Visit 12) | 35 implants |
| ANKYLOS C/X Implant A 6.6 | At Least One Surface With Plaque. | Any plaque at 6-months post permanent restoration (Visit 9) | 32 implants |
| ANKYLOS C/X Implant A 6.6 | At Least One Surface With Plaque. | Any plaque at permanent restoration (Visit 8) | 14 implants |
| ANKYLOS C/X Implant A 6.6 | At Least One Surface With Plaque. | Any plaque at 1-year post permanent restoration (Visit 10) | 35 implants |
| ANKYLOS C/X Implant A 6.6 | At Least One Surface With Plaque. | Any plaque at 2-years post permanent restoration (Visit 11) | 28 implants |
| ANKYLOS C/X Implant A 6.6 | At Least One Surface With Plaque. | Any plaque at 5-years post permanent restoration (Visit 14) | 23 implants |
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).
Time frame: At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).
Population: Intention to treat
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Implant Stability | Implant stability at Visit 3 | Yes | 37 Implants |
| ANKYLOS C/X Implant A 6.6 | Implant Stability | Implant stability at Visit 3 | No | 35 Implants |
| ANKYLOS C/X Implant A 6.6 | Implant Stability | Implant stability at Visit 5 | No | 5 Implants |
| ANKYLOS C/X Implant A 6.6 | Implant Stability | Implant stability at Visit 5 | Yes | 67 Implants |
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.
Time frame: 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).
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) at Subject's Tissue Level | Permanent restoration (Visit 8) | 1.43 millimeters (mm) | Standard Deviation 0.7 |
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) at Subject's Tissue Level | 1-year post permanent restoration (Visit 10) | 1.44 millimeters (mm) | Standard Deviation 0.84 |
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) at Subject's Tissue Level | 3-years post permanent restoration (Visit 12) | 1.20 millimeters (mm) | Standard Deviation 0.74 |
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) at Subject's Tissue Level | 5-years post permanent restoration (Visit 14) | 1.17 millimeters (mm) | Standard Deviation 0.71 |
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.
Time frame: 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).
Population: Intention to treat group. 2 implants missing from the analysis at Visit 14 (5-year follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) on Implant Level. | Permanent restoration (Visit 8) | 1.41 millimeters (mm) | Standard Deviation 1.13 |
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) on Implant Level. | 1-year post permanent restoration (Visit 10) | 1.42 millimeters (mm) | Standard Deviation 1.25 |
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) on Implant Level. | 3-years post permanent restoration (Visit 12) | 1.21 millimeters (mm) | Standard Deviation 1.36 |
| ANKYLOS C/X Implant A 6.6 | Mean Marginal Bone Level (MBL) on Implant Level. | 5-years post permanent restoration (Visit 14) | 1.17 millimeters (mm) | Standard Deviation 1.29 |
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.
Time frame: 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).
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Mean Probing Pocket Depth (PPD) at Subject Level. | Permanent restoration (Visit 8) | 3.4 millimeter (mm) | Standard Deviation 0.4 |
| ANKYLOS C/X Implant A 6.6 | Mean Probing Pocket Depth (PPD) at Subject Level. | 6-months post permanent restoration (Visit 9) | 3.5 millimeter (mm) | Standard Deviation 4.7 |
| ANKYLOS C/X Implant A 6.6 | Mean Probing Pocket Depth (PPD) at Subject Level. | 1-year post permanent restoration (Visit 10) | 4.1 millimeter (mm) | Standard Deviation 4.7 |
| ANKYLOS C/X Implant A 6.6 | Mean Probing Pocket Depth (PPD) at Subject Level. | 2-years post permanent restoration (Visit 11) | 3.4 millimeter (mm) | Standard Deviation 4.4 |
| ANKYLOS C/X Implant A 6.6 | Mean Probing Pocket Depth (PPD) at Subject Level. | 3-years post permanent restoration (Visit 12) | 3.9 millimeter (mm) | Standard Deviation 4.9 |
| ANKYLOS C/X Implant A 6.6 | Mean Probing Pocket Depth (PPD) at Subject Level. | 5-years post permanent restoration (Visit 14) | 3.4 millimeter (mm) | Standard Deviation 4.4 |
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.
Time frame: 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).
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Oral Health Impact Profile 14 (OHIP-14) | Overall (Q1-14) at 2-years post permanent restoration | 4.5 units on a scale | Standard Deviation 6.09 |
| ANKYLOS C/X Implant A 6.6 | Oral Health Impact Profile 14 (OHIP-14) | Overall (Q1-14) at 5-years post permanent restoration | 6.9 units on a scale | Standard Deviation 8.84 |
| ANKYLOS C/X Implant A 6.6 | Oral Health Impact Profile 14 (OHIP-14) | Overall (Q1-14) at pre-surgical planing (Visit 2) | 27.8 units on a scale | Standard Deviation 16.13 |
| ANKYLOS C/X Implant A 6.6 | Oral Health Impact Profile 14 (OHIP-14) | Overall (Q1-14) at 6-months post permanent restoration | 5.2 units on a scale | Standard Deviation 7.67 |
| ANKYLOS C/X Implant A 6.6 | Oral Health Impact Profile 14 (OHIP-14) | Overall (Q1-14) at 1-year post permanent restoration | 8.3 units on a scale | Standard Deviation 10.85 |
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.
Time frame: 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).
Population: Intention to treat
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 1-year post permanent restoration | Original prosthesis still in place | 10 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 1-year post permanent restoration | Original prosthesis not in place | 1 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 2-years post permanent restoration | Original prosthesis still in place | 10 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 2-years post permanent restoration | Original prosthesis not in place | 0 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 3-years post permanent restoration | Original prosthesis still in place | 8 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 3-years post permanent restoration | Original prosthesis not in place | 0 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 5-years post permanent restoration | Original prosthesis still in place | 7 Prosthesis (Bridges) |
| ANKYLOS C/X Implant A 6.6 | Prosthetic Survival Rate on Subject Level | At 5-years post permanent restoration | Original prosthesis not in place | 0 Prosthesis (Bridges) |