Trial Outcomes & Findings for Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study (NCT NCT02656823)
NCT ID: NCT02656823
Last Updated: 2024-02-28
Results Overview
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.
COMPLETED
NA
12 participants
At Visit 14, 5 years after permanent restoration (PR).
2024-02-28
Participant Flow
Unit of analysis: Implant
Participant milestones
| Measure |
ANKYLOS C/X Implant A 6.6
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Overall Study
STARTED
|
12 72
|
|
Overall Study
Permanent Restoration (PR), Visit 8
|
11 62
|
|
Overall Study
COMPLETED
|
7 41
|
|
Overall Study
NOT COMPLETED
|
5 31
|
Reasons for withdrawal
| Measure |
ANKYLOS C/X Implant A 6.6
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ANKYLOS C/X Implant A 6.6
n=12 Participants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Age, Continuous
|
60.2 Years
STANDARD_DEVIATION 12.19 • n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: At Visit 14, 5 years after permanent restoration (PR).Population: Intention to treat.
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.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=60 Implants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Implant Survival Rate
Implants confirmed as survived
|
41 Implants
|
|
Implant Survival Rate
Implants confirmed to be failures
|
19 Implants
|
SECONDARY outcome
Timeframe: At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).Population: Intention to treat
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).
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=72 Implants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Implant Stability
Implant stability at Visit 3 · No
|
35 Implants
|
|
Implant Stability
Implant stability at Visit 3 · Yes
|
37 Implants
|
|
Implant Stability
Implant stability at Visit 5 · No
|
5 Implants
|
|
Implant Stability
Implant stability at Visit 5 · Yes
|
67 Implants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=11 Participants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Mean Marginal Bone Level (MBL) at Subject's Tissue Level
Permanent restoration (Visit 8)
|
1.43 millimeters (mm)
Standard Deviation 0.70
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=62 implants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Mean Marginal Bone Level (MBL) on Implant Level.
Permanent restoration (Visit 8)
|
1.41 millimeters (mm)
Standard Deviation 1.13
|
|
Mean Marginal Bone Level (MBL) on Implant Level.
1-year post permanent restoration (Visit 10)
|
1.42 millimeters (mm)
Standard Deviation 1.25
|
|
Mean Marginal Bone Level (MBL) on Implant Level.
3-years post permanent restoration (Visit 12)
|
1.21 millimeters (mm)
Standard Deviation 1.36
|
|
Mean Marginal Bone Level (MBL) on Implant Level.
5-years post permanent restoration (Visit 14)
|
1.17 millimeters (mm)
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 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
PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=11 Participants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Mean Probing Pocket Depth (PPD) at Subject Level.
Permanent restoration (Visit 8)
|
3.4 millimeter (mm)
Standard Deviation 0.4
|
|
Mean Probing Pocket Depth (PPD) at Subject Level.
6-months post permanent restoration (Visit 9)
|
3.5 millimeter (mm)
Standard Deviation 4.7
|
|
Mean Probing Pocket Depth (PPD) at Subject Level.
1-year post permanent restoration (Visit 10)
|
4.1 millimeter (mm)
Standard Deviation 4.7
|
|
Mean Probing Pocket Depth (PPD) at Subject Level.
2-years post permanent restoration (Visit 11)
|
3.4 millimeter (mm)
Standard Deviation 4.4
|
|
Mean Probing Pocket Depth (PPD) at Subject Level.
3-years post permanent restoration (Visit 12)
|
3.9 millimeter (mm)
Standard Deviation 4.9
|
|
Mean Probing Pocket Depth (PPD) at Subject Level.
5-years post permanent restoration (Visit 14)
|
3.4 millimeter (mm)
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 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
Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually).
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=62 implants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
At Least One Surface With Plaque.
Any plaque at permanent restoration (Visit 8)
|
14 implants
|
|
At Least One Surface With Plaque.
Any plaque at 6-months post permanent restoration (Visit 9)
|
32 implants
|
|
At Least One Surface With Plaque.
Any plaque at 1-year post permanent restoration (Visit 10)
|
35 implants
|
|
At Least One Surface With Plaque.
Any plaque at 2-years post permanent restoration (Visit 11)
|
28 implants
|
|
At Least One Surface With Plaque.
Any plaque at 3-years post permanent restoration (Visit 12)
|
35 implants
|
|
At Least One Surface With Plaque.
Any plaque at 5-years post permanent restoration (Visit 14)
|
23 implants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=62 implants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Any Bleeding on Implant (BoP)
Any surface with BoP at permanent restoration (Visit 8)
|
24 implants
|
|
Any Bleeding on Implant (BoP)
Any surface with BoP at 6-months post permanent restoration (Visit 9)
|
44 implants
|
|
Any Bleeding on Implant (BoP)
Any surface with BoP at 1-year post permanent restoration (Visit 10)
|
39 implants
|
|
Any Bleeding on Implant (BoP)
Any surface with BoP at 2-years post permanent restoration (Visit 11)
|
29 implants
|
|
Any Bleeding on Implant (BoP)
Any surface with BoP at 3-years post permanent restoration (Visit 12)
|
29 implants
|
|
Any Bleeding on Implant (BoP)
Any surface with BoP at 5-years post permanent restoration (Visit 14)
|
15 implants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=12 Participants
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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
A prosthetic restoration was considered a survived if the original restoration was still in place, regardless of its condition, at the follow-up visit.
Outcome measures
| Measure |
ANKYLOS C/X Implant A 6.6
n=11 Prosthesis (Bridges)
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Prosthetic Survival Rate on Subject Level
At 1-year post permanent restoration · Original prosthesis still in place
|
10 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 1-year post permanent restoration · Original prosthesis not in place
|
1 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 2-years post permanent restoration · Original prosthesis still in place
|
10 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 2-years post permanent restoration · Original prosthesis not in place
|
0 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 3-years post permanent restoration · Original prosthesis still in place
|
8 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 3-years post permanent restoration · Original prosthesis not in place
|
0 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 5-years post permanent restoration · Original prosthesis still in place
|
7 Prosthesis (Bridges)
|
|
Prosthetic Survival Rate on Subject Level
At 5-years post permanent restoration · Original prosthesis not in place
|
0 Prosthesis (Bridges)
|
Adverse Events
ANKYLOS C/X Implant A 6.6
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ANKYLOS C/X Implant A 6.6
n=12 participants at risk
Subjects treated with ANKYLOS C/X Implant A 6.6 mm.
|
|---|---|
|
Product Issues
Dental implant related event
|
66.7%
8/12 • Number of events 11 • 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)
|
|
Product Issues
Dental abutment related event
|
16.7%
2/12 • Number of events 2 • 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)
|
|
Product Issues
Dental prosthesis related event
|
16.7%
2/12 • Number of events 5 • 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)
|
|
Product Issues
Porcelain chipping
|
41.7%
5/12 • Number of events 10 • 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)
|
|
Investigations
Peri-implant tissue related event
|
33.3%
4/12 • Number of events 4 • 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)
|
|
Cardiac disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • 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)
|
|
Infections and infestations
Hand infection
|
8.3%
1/12 • Number of events 1 • 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)
|
|
Musculoskeletal and connective tissue disorders
Back injury and spinal fusion surgery
|
8.3%
1/12 • Number of events 1 • 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)
|
|
Skin and subcutaneous tissue disorders
Nickel allergy
|
8.3%
1/12 • Number of events 1 • 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)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm neck region
|
8.3%
1/12 • Number of events 1 • 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)
|
|
Musculoskeletal and connective tissue disorders
Lumbar vertebrae surgery
|
8.3%
1/12 • Number of events 1 • 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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place