Trial Outcomes & Findings for Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population (NCT NCT01389258)
NCT ID: NCT01389258
Last Updated: 2019-10-15
Results Overview
Implant survival rate evaluated clinically and radiographically.
COMPLETED
NA
45 participants
Measured at the 3-year follow-up visit after implant loading.
2019-10-15
Participant Flow
Unit of analysis: Implants
Participant milestones
| Measure |
OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Overall Study
STARTED
|
45 47
|
|
Overall Study
COMPLETED
|
40 42
|
|
Overall Study
NOT COMPLETED
|
5 5
|
Reasons for withdrawal
| Measure |
OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population
Baseline characteristics by cohort
| Measure |
OsseoSpeed™ TX
n=45 Participants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at the 3-year follow-up visit after implant loading.Population: Intention to treat (ITT), including all participants that received at least one implant, a total of 45 subjects (47 implants). A total of 5 subjects (5 implants) had been lost to follow-up at time of the 3-year follow-up visit, giving an overall number of 40 subjects (42 implants) as basis for the analysis of three year survival rate.
Implant survival rate evaluated clinically and radiographically.
Outcome measures
| Measure |
OsseoSpeed™ TX
n=42 Implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Implant Survival
|
42 Implants
|
SECONDARY outcome
Timeframe: Measured at the 3-year follow-up visit after implant loading.Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the All Patients Treated (APT) population.
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Outcome measures
| Measure |
OsseoSpeed™ TX
n=42 implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Implant Stability
|
42 implants
|
SECONDARY outcome
Timeframe: Measured at the 3-year follow-up visit after implant loading.Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
Marginal Bone Level (mm) determined from radiographs and expressed as a difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).
Outcome measures
| Measure |
OsseoSpeed™ TX
n=32 Implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Marginal Bone Level Alteration
|
0.52 millimeter
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Measured at implant loading and at the 3-year follow-up visit after loading.Population: 40 subjects (42 implants) completed the 3 years follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Outcome measures
| Measure |
OsseoSpeed™ TX
n=32 Implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
|
-0.26 millimeter
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Measured at implant loading and at the 3-year follow-up visit after loading.Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Outcome measures
| Measure |
OsseoSpeed™ TX
n=32 implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
|
2 implants
|
SECONDARY outcome
Timeframe: Measured at the 3-year follow-up visit after implant loading.Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.
Outcome measures
| Measure |
OsseoSpeed™ TX
n=32 implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Presence of Plaque
|
2 implants
|
SECONDARY outcome
Timeframe: Measured at implant loading and at the 3-year follow-up visit after loading.Population: 40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).
Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm. Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.
Outcome measures
| Measure |
OsseoSpeed™ TX
n=32 implants
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
|
|---|---|
|
Gingival Zenith Score
|
-0.03 millimeter
Standard Deviation 0.74
|
Adverse Events
OsseoSpeed™ TX
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Manager Global Clinical Research
Dentsply Sirona Implants, Mölndal, SWEDEN
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60