Trial Outcomes & Findings for Straumann Roxolid Multi-Center Study (NCT NCT01842958)
NCT ID: NCT01842958
Last Updated: 2018-02-15
Results Overview
Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline (implant placement) and 12 months post loading
Results posted on
2018-02-15
Participant Flow
Participant milestones
| Measure |
3.3 mm Implant Diameter
Placement of a Straumann Bone Level Implant, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
Placement of a Straumann Bone Level Implant, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
Randomized
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
3.3 mm Implant Diameter
Placement of a Straumann Bone Level Implant, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
Placement of a Straumann Bone Level Implant, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
Baseline characteristics by cohort
| Measure |
3.3 mm Implant Diameter
n=25 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=25 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 13.96 • n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
49.6 years
STANDARD_DEVIATION 14.20 • n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
51.2 years
STANDARD_DEVIATION 14.04 • n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
17 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
32 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
8 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
18 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
4 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
7 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
21 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
43 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
5 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
12 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
1 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
2 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
19 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
35 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
0 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
1 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
25 Participants
n=7 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
50 Participants
n=5 Participants • One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the Safety Population/Demographics.
|
PRIMARY outcome
Timeframe: Baseline (implant placement) and 12 months post loadingPopulation: modified Intent-to-Treat population
Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=26 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=24 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Mean Crestal Bone Level Change
|
0.27 mm
Standard Deviation 0.34
|
0.48 mm
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loadingPopulation: modified Intent-to-Treat population
Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=26 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=24 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Additional Mean Crestal Bone Level Changes
change surgery to 6 months
|
0.52 mm
Standard Deviation 0.53
|
0.73 mm
Standard Deviation 0.52
|
|
Additional Mean Crestal Bone Level Changes
Change surgery to loading
|
0.08 mm
Standard Deviation 0.15
|
0.34 mm
Standard Deviation 0.38
|
|
Additional Mean Crestal Bone Level Changes
change surgery to 12 months
|
0.35 mm
Standard Deviation 0.33
|
0.83 mm
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 25 days, 6 months post loading, and 12 months post loadingPopulation: modified Intent-to-Treat population
Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant)
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=26 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=24 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Implant Success Rate
25 days (implant loading) · Successful implant
|
25 Participants
|
23 Participants
|
|
Implant Success Rate
25 days (implant loading) · Non successful implant
|
1 Participants
|
1 Participants
|
|
Implant Success Rate
25 days (implant loading) · Not available for evaluation
|
0 Participants
|
0 Participants
|
|
Implant Success Rate
6 months post loading · Successful implant
|
26 Participants
|
23 Participants
|
|
Implant Success Rate
6 months post loading · Non successful implant
|
0 Participants
|
0 Participants
|
|
Implant Success Rate
6 months post loading · Not available for evaluation
|
0 Participants
|
1 Participants
|
|
Implant Success Rate
12 months post loading · Successful implant
|
24 Participants
|
24 Participants
|
|
Implant Success Rate
12 months post loading · Non successful implant
|
0 Participants
|
0 Participants
|
|
Implant Success Rate
12 months post loading · Not available for evaluation
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days, 25 days, 6 months post loading, and 12 months post loadingPopulation: modified Intent-to-Treat population
Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=26 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=24 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Implant Survival Rate
6 months post implant loading · Surviving implant
|
26 Participants
|
23 Participants
|
|
Implant Survival Rate
7 days (post-op) · Surviving implant
|
26 Participants
|
24 Participants
|
|
Implant Survival Rate
7 days (post-op) · Non-surviving implant
|
0 Participants
|
0 Participants
|
|
Implant Survival Rate
7 days (post-op) · Not available for evaluation
|
0 Participants
|
0 Participants
|
|
Implant Survival Rate
25 days (implant loading) · Surviving implant
|
26 Participants
|
24 Participants
|
|
Implant Survival Rate
25 days (implant loading) · Non-surviving implant
|
0 Participants
|
0 Participants
|
|
Implant Survival Rate
25 days (implant loading) · Not available for evaluation
|
0 Participants
|
0 Participants
|
|
Implant Survival Rate
6 months post implant loading · Non-surviving implant
|
0 Participants
|
0 Participants
|
|
Implant Survival Rate
6 months post implant loading · Not available for evaluation
|
0 Participants
|
1 Participants
|
|
Implant Survival Rate
12 months post implant loading · Surviving implant
|
24 Participants
|
24 Participants
|
|
Implant Survival Rate
12 months post implant loading · Non-surviving implant
|
0 Participants
|
0 Participants
|
|
Implant Survival Rate
12 months post implant loading · Not available for evaluation
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months to 12 months post loadingPopulation: Modified Intent-to-Treat population. Data was not available from 4 subjects in the 3.3 mm arm and 3 subjects in the 4.1 arm
Soft tissue measurements include: CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters.
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=22 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=21 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Gingival Recession
CLI
|
0.1 mm
Standard Deviation 1.04
|
0.2 mm
Standard Deviation 2.14
|
|
Gingival Recession
IPm
|
-0.9 mm
Standard Deviation 1.4
|
-0.9 mm
Standard Deviation 1.96
|
|
Gingival Recession
IPd
|
-0.5 mm
Standard Deviation 1.54
|
-0.9 mm
Standard Deviation 1.90
|
|
Gingival Recession
CLTm
|
0.7 mm
Standard Deviation 2.59
|
0.1 mm
Standard Deviation 2.76
|
|
Gingival Recession
CLTd
|
0.8 mm
Standard Deviation 1.99
|
-0.1 mm
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Duration of the study from surgical visit to the 12 months post-loading visitPopulation: Safety population. One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the safety population.
Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes "possibly related", "probably related" and "related").
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=25 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=25 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Number of Participants With Adverse Events and Adverse Device Effects
Subjects without adverse events
|
18 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events and Adverse Device Effects
Subjects with one or more adverse events
|
7 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events and Adverse Device Effects
subjects with adverse events related to device
|
1 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events and Adverse Device Effects
Subjects with adverse events related to procedure
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 months post loadingPopulation: Modified Intent-to-Treat population. Data was not available for 3 subjects in 3.3 mm implant arm and for 2 subjects in the 4.1 mm implant arm.
Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain. General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain)
Outcome measures
| Measure |
3.3 mm Implant Diameter
n=23 Participants
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=22 Participants
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Subject Satisfaction
General Satisfaction
|
97.7 units on a scale
Standard Deviation 3.03
|
98.2 units on a scale
Standard Deviation 3.54
|
|
Subject Satisfaction
Pain
|
6.0 units on a scale
Standard Deviation 19.75
|
2.7 units on a scale
Standard Deviation 8.05
|
Adverse Events
3.3 mm Implant Diameter
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
4.1 mm Implant Diameter
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.3 mm Implant Diameter
n=25 participants at risk
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=25 participants at risk
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
Other adverse events
| Measure |
3.3 mm Implant Diameter
n=25 participants at risk
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
4.1 mm Implant Diameter
n=25 participants at risk
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
|
|---|---|---|
|
Surgical and medical procedures
Prosthetic related complication
|
20.0%
5/25 • Number of events 9 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
16.0%
4/25 • Number of events 5 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Surgical and medical procedures
Pain at implant site
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Surgical and medical procedures
Implant hit root of adjacent tooth
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Musculoskeletal and connective tissue disorders
Minimal bone loss around implant
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Musculoskeletal and connective tissue disorders
Implant mobility
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Musculoskeletal and connective tissue disorders
Radiolucency around implant
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Musculoskeletal and connective tissue disorders
Oral ulcer
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Musculoskeletal and connective tissue disorders
Pain due to bruxism
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
General disorders
Tooth caries
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
General disorders
Adjacent tooth fracutre
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Infections and infestations
Vaginal yeast infection
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Product Issues
Adaptor broke in implant
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Nervous system disorders
Burning sensation on labial mucosa
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
|
Nervous system disorders
Post op paraesthesia lower left labial mucosa
|
0.00%
0/25 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from implant surgery to 12 months-post loading, around 13 months total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60