Trial Outcomes & Findings for Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw (NCT NCT00820235)
NCT ID: NCT00820235
Last Updated: 2020-05-07
Results Overview
Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.
COMPLETED
NA
141 participants
Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
2020-05-07
Participant Flow
Unit of analysis: Implants
Participant milestones
| Measure |
Group-A. OsseoSpeed™ Implant
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Overall Study
STARTED
|
48 48
|
49 49
|
44 44
|
|
Overall Study
COMPLETED
|
33 33
|
28 28
|
27 27
|
|
Overall Study
NOT COMPLETED
|
15 15
|
21 21
|
17 17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw
Baseline characteristics by cohort
| Measure |
Group-A. OsseoSpeed™ Implant
n=48 Participants
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=49 Participants
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=44 Participants
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 15 • n=5 Participants
|
46 years
STANDARD_DEVIATION 17 • n=7 Participants
|
46 years
STANDARD_DEVIATION 16 • n=5 Participants
|
45 years
STANDARD_DEVIATION 16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
40 participants
n=7 Participants
|
37 participants
n=5 Participants
|
115 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loadingPopulation: A total of 88 subjects completed the 5-year follow-up visit. Five radiographs (two in group A, two in group B and one in group C) were not possible to evaluate, giving an overall number of 83 subjects (83 implants) as basis for the analysis of Gingival Zenith score change.
Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.
Outcome measures
| Measure |
Group-A. OsseoSpeed™ Implant
n=31 Implants
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=26 Implants
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=26 Implants
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
|
0.08 Millimeter
Standard Deviation 0.65
|
-0.10 Millimeter
Standard Deviation 1.00
|
0.00 Millimeter
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Evaluated at time of implant installation and at the 5-year follow-up visit.Population: A total of 88 subjects completed the 5-year follow-up visit. Three radiographs (all in group C) were not possible to evaluate, giving an overall number of 85 subjects (85 implants) as basis for the analysis of marginal bone level change.
Marginal Bone Level determined from radiographs and expressed as the 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 at the 5-year follow-up visit compared to values obtained at time of implant placement.
Outcome measures
| Measure |
Group-A. OsseoSpeed™ Implant
n=33 Participants
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=28 Participants
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=24 Participants
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Marginal Bone Level Alterations
|
-0.16 Millimeter
Standard Deviation 0.45
|
-0.92 Millimeter
Standard Deviation 0.70
|
-0.81 Millimeter
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Measured at time of loading of permanent restoration and at the 5-year follow-up.Population: A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the PPD assessment.
Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Outcome measures
| Measure |
Group-A. OsseoSpeed™ Implant
n=33 Participants
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=28 Participants
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=27 Participants
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
|
0.08 Millimeter
Standard Deviation 0.88
|
-0.06 Millimeter
Standard Deviation 0.88
|
-0.09 Millimeter
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Measured at the implant loading and at the 5-year follow-up after loading.Population: A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the assessment of BoP change.
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.
Outcome measures
| Measure |
Group-A. OsseoSpeed™ Implant
n=33 Surfaces
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=28 Surfaces
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=27 Surfaces
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.
|
0.13 Change in proportion of surfaces
Standard Deviation 0.38
|
0.04 Change in proportion of surfaces
Standard Deviation 0.34
|
0.07 Change in proportion of surfaces
Standard Deviation 0.33
|
Adverse Events
Group-A. OsseoSpeed™ Implant
Group-B. NobelSpeedy™ Replace® Implant
Group-C. NanoTite™ Certain® PREVAIL® Implant
Serious adverse events
| Measure |
Group-A. OsseoSpeed™ Implant
n=48 participants at risk
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=49 participants at risk
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=44 participants at risk
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Reproductive system and breast disorders
Breast cancer
|
0.00%
0/48 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/44 • 5 years
|
|
Infections and infestations
Hospitalized due to fever after mastectomy
|
0.00%
0/48 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/44 • 5 years
|
|
Renal and urinary disorders
Hospitalized for partial nephrectomy
|
0.00%
0/48 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/44 • 5 years
|
|
Hepatobiliary disorders
Hospitalised for gall bladder surgery
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/44 • 5 years
|
|
Cardiac disorders
Hospitalized for follow-up on chest pains
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hospitalized for spine fusion surgery
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Hospitalized for gastric surgery
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Hospitalized for surgery of infected appendix
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/44 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hospitalized for knee replacement
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/44 • 5 years
|
|
Cardiac disorders
Hospitalization after heart attack
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Cardiac disorders
Death caused by heart attack
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/44 • 5 years
|
|
Psychiatric disorders
Hospitalized due to episode of bi-polar disorder
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hospitalized for fractured leg after an accident
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized due to pneumonia
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/44 • 5 years
|
|
Vascular disorders
Hospitalization due to hypertension
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colon cancer
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Infections and infestations
Hospitalized for treatment of infection after vaccination
|
2.1%
1/48 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/44 • 5 years
|
|
Reproductive system and breast disorders
Hospitalized due to menstrual hemorrhage
|
0.00%
0/48 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/44 • 5 years
|
Other adverse events
| Measure |
Group-A. OsseoSpeed™ Implant
n=48 participants at risk
Subjects that had OsseoSpeed™ implants installed.
|
Group-B. NobelSpeedy™ Replace® Implant
n=49 participants at risk
Subjects that had NobelSpeedy™ Replace® implants installed
|
Group-C. NanoTite™ Certain® PREVAIL® Implant
n=44 participants at risk
Subjects that had NanoTite™ Certain® PREVAIL® implants installed
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Study implant failled to osseointegrate
|
0.00%
0/48 • 5 years
|
16.3%
8/49 • Number of events 8 • 5 years
|
13.6%
6/44 • Number of events 6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Study implant temporary mobile
|
0.00%
0/48 • 5 years
|
0.00%
0/49 • 5 years
|
6.8%
3/44 • Number of events 3 • 5 years
|
|
Product Issues
Restoration failure
|
12.5%
6/48 • Number of events 6 • 5 years
|
16.3%
8/49 • Number of events 8 • 5 years
|
2.3%
1/44 • Number of events 1 • 5 years
|
|
Product Issues
Loose abutments
|
6.2%
3/48 • Number of events 3 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/44 • 5 years
|
|
General disorders
Other
|
2.1%
1/48 • Number of events 1 • 5 years
|
18.4%
9/49 • Number of events 9 • 5 years
|
4.5%
2/44 • Number of events 2 • 5 years
|
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