Trial Outcomes & Findings for Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone (NCT NCT00807456)
NCT ID: NCT00807456
Last Updated: 2022-11-17
Results Overview
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
At baseline and 16 weeks
Results posted on
2022-11-17
Participant Flow
Participant milestones
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|
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Overall Study
STARTED
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65
|
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Overall Study
Surgical Re-entry (Implant Placement + 16-17 Weeks)
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65
|
|
Overall Study
COMPLETED
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57
|
|
Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
Baseline characteristics by cohort
| Measure |
Subjects Treated With ASTRA TECH Implant System, OsseoSpeed™ Profile Implant
n=65 Participants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|
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Age, Continuous
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49.05 years
STANDARD_DEVIATION 13.974 • n=39 Participants
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Sex: Female, Male
Female
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33 Participants
n=39 Participants
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Sex: Female, Male
Male
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32 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: At baseline and 16 weeksPopulation: Per-protocol analysis set
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
Outcome measures
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
n=65 Implants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 12 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 24 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 36 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|---|---|---|
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Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
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-0.02 mm
Standard Deviation 0.49
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—
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—
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—
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SECONDARY outcome
Timeframe: 21 weeks, 12 months, 24 months and 36 months post implant placement.Population: Per-protocol analysis set
The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.
Outcome measures
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
n=65 Implants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 12 Months Post Implant Placement
n=64 Implants
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 24 Months Post Implant Placement
n=59 Implants
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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Subjects Assessed at 36 Months Post Implant Placement
n=57 Implants
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|---|---|---|
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Implant Survival Rate
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65 Implants
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64 Implants
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59 Implants
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57 Implants
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SECONDARY outcome
Timeframe: Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placementPopulation: Per-protocol analysis set. All subjects/implants available for each visit are included in below analyses.
MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis.
Outcome measures
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
n=56 Implants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 12 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 24 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 36 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|---|---|---|
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Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
Implant Placement to re-entry (implant placement + 16 weeks)
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-0.28 mm
Standard Deviation 0.68
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—
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—
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—
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Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
Implant placement to permanent restoration (implant placement + 21 weeks)
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-0.48 mm
Standard Deviation 0.74
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—
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—
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—
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Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
Implant placement to implant placement + 12 months
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-0.29 mm
Standard Deviation 1.10
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—
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—
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—
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Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
Implant placement to implant placement + 36 months
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-0.57 mm
Standard Deviation 1.60
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—
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—
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—
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SECONDARY outcome
Timeframe: 21 weeks, 12 months, 24 months, and 36 months post implant placementPopulation: Per-protocol analysis set. All subjects available for each visit are included in below analyses.
BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.
Outcome measures
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
n=65 Implants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 12 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 24 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 36 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|---|---|---|
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Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
Permanent restoration 21 weeks after implant placement
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2 Implants with BoP
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—
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—
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—
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Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
12 months after implant placement
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20 Implants with BoP
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—
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—
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—
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Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
24 months after implant placement
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16 Implants with BoP
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—
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—
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—
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Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
36 months after implant placement
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21 Implants with BoP
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—
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—
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—
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SECONDARY outcome
Timeframe: Baseline and 12 months, 24 months, and 36 months post implant placementPopulation: Per-protocol analysis set. All subjects available for each visit are included in below analyses.
PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level.
Outcome measures
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
n=63 Implants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 12 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 24 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 36 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|---|---|---|
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Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
Permanent restoration to 12 months post implant placement
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0.28 PPD in mm
Standard Deviation 0.73
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—
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—
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—
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Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
Permanent restoration to 24 months post implant placement
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0.31 PPD in mm
Standard Deviation 0.68
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—
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—
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—
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Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
Permanent restoration to 36 months post implant placement
|
0.36 PPD in mm
Standard Deviation 0.85
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—
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—
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—
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SECONDARY outcome
Timeframe: Baseline and 12 months, 24 months, and 36 months post implant placementPopulation: Per-protocol analysis set. All subjects available for each visit are included in below analyses.
CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level.
Outcome measures
| Measure |
Subjects Treated With OsseoSpeed™ Profile Implant
n=63 Implants
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 12 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 24 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
|
Subjects Assessed at 36 Months Post Implant Placement
Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|---|---|---|
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Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
Permanent restoration to 12 months post implant placement
|
0.02 CAL in mm
Standard Deviation 0.54
|
—
|
—
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—
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Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
Permanent restoration to 24 months post implant placement
|
0.14 CAL in mm
Standard Deviation 0.57
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—
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—
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—
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Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
Permanent restoration to 36 months post implant placement
|
0.11 CAL in mm
Standard Deviation 0.85
|
—
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—
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—
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Adverse Events
ASTRA TECH Implant System, OsseoSpeed™ Profile
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ASTRA TECH Implant System, OsseoSpeed™ Profile
n=65 participants at risk
ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
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|---|---|
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Surgical and medical procedures
Hip surgery
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1.5%
1/65 • Number of events 1 • Up to 3 years post implant placement
|
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Skin and subcutaneous tissue disorders
Melanoma
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1.5%
1/65 • Number of events 1 • Up to 3 years post implant placement
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60