Trial Outcomes & Findings for Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems. (NCT NCT00746187)
NCT ID: NCT00746187
Last Updated: 2016-04-13
Results Overview
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
COMPLETED
NA
36 participants
3 years after implant placement (baseline)
2016-04-13
Participant Flow
Participant milestones
| Measure |
ASTRA TECH Implant System; Fixture ST
Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
|
Biomet 3i; Osseotite® Implants
Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Baseline characteristics by cohort
| Measure |
ASTRA TECH Implant System; Fixture ST
n=18 Participants
Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
|
Biomet 3i; Osseotite® Implants
n=18 Participants
Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 12 • n=5 Participants
|
51 years
STANDARD_DEVIATION 11 • n=7 Participants
|
53 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years after implant placement (baseline)Population: Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
Outcome measures
| Measure |
ASTRA TECH Implant System; Fixture ST
n=36 Implants
Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
|
Biomet 3i; Osseotite® Implants
n=38 Implants
Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
|
|---|---|---|
|
Marginal Bone Level Changes
|
-0.25 millimeter
Standard Deviation 0.60
|
-0.50 millimeter
Standard Deviation 0.93
|
Adverse Events
ASTRA TECH Implant System; Fixture ST
Biomet 3i; Osseotite® Implants
Serious adverse events
| Measure |
ASTRA TECH Implant System; Fixture ST
n=18 participants at risk
Ø 4.5 cm in lengths 9-13 mm
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
|
Biomet 3i; Osseotite® Implants
n=18 participants at risk
Ø 4.0 cm in lengths 8.5-13 mm
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
|
|---|---|---|
|
Reproductive system and breast disorders
Advanced breast cancer
|
0.00%
0/18
|
5.6%
1/18
|
|
Reproductive system and breast disorders
Prostate cancer
|
5.6%
1/18
|
0.00%
0/18
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Manager Global Clinical Research
DENTSPLY Implants
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60