Trial Outcomes & Findings for Immediate or Delayed Provisionalization in Posterior Healed Sites (NCT NCT02387970)
NCT ID: NCT02387970
Last Updated: 2023-03-06
Results Overview
Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
Immediate Provisionalization
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Immediate Provisionalization
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Overall Study
Did not complete 1-year follow up
|
1
|
2
|
Baseline Characteristics
Immediate or Delayed Provisionalization in Posterior Healed Sites
Baseline characteristics by cohort
| Measure |
Immediate Provisionalization
n=26 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=23 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
n=99 Participants
|
48.8 years
n=107 Participants
|
46.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Tooth Type
Premolar
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Tooth Type
Molar
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Arch
Maxilla
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Arch
Mandible
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Only includes individuals with analyzable data.
Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Outcome measures
| Measure |
Immediate Provisionalization
n=24 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=21 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Radiographic Bone Level Mesial to the Implant
|
1.26 Millimeters
Standard Deviation 1.10
|
1.85 Millimeters
Standard Deviation 1.16
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Only includes individuals who completed the 1-year follow up.
Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Outcome measures
| Measure |
Immediate Provisionalization
n=25 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=21 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Radiographic Bone Level Mesial to the Implant
|
1.14 Millimeters
Standard Deviation 1.20
|
1.57 Millimeters
Standard Deviation 1.17
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Only includes individuals with analyzable data.
Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Outcome measures
| Measure |
Immediate Provisionalization
n=22 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=20 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Radiographic Bone Level Distal to the Implant
|
1.36 Millimeters
Standard Deviation 1.27
|
1.82 Millimeters
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Only includes individuals who completed the 1-year follow up.
Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.
Outcome measures
| Measure |
Immediate Provisionalization
n=23 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=21 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Radiographic Bone Level Distal to the Implant
|
1.22 Millimeters
Standard Deviation 1.40
|
1.60 Millimeters
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsMeasurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure.
Outcome measures
| Measure |
Immediate Provisionalization
n=22 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=17 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Mean Change in Peri-implant Mucosal Margin Level
|
0.28 millimeters of tissue
Standard Deviation 0.96
|
-0.10 millimeters of tissue
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsMeasurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure.
Outcome measures
| Measure |
Immediate Provisionalization
n=21 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=16 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Mean Change in Peri-implant Mucosal Margin Level
|
0.27 millimeters
Standard Deviation 0.80
|
-0.20 millimeters
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsMeasurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure.
Outcome measures
| Measure |
Immediate Provisionalization
n=23 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=20 Participants
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Mean Change in Peri-implant Mucosal Margin Level
|
0.10 millimeters
Standard Deviation 0.76
|
-0.08 millimeters
Standard Deviation 0.67
|
Adverse Events
Immediate Provisionalization
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Delayed Provisionalization
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Provisionalization
n=26 participants at risk
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Immediate provisionalization: Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
Delayed Provisionalization
n=23 participants at risk
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
Delayed provisionalization: Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implant: Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crown: A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
|
|---|---|---|
|
Product Issues
Prosthetic Screw Loosening - Multiple
|
3.8%
1/26 • Number of events 1 • Up to 36 months from procedure
|
8.7%
2/23 • Number of events 2 • Up to 36 months from procedure
|
|
Product Issues
Crown fracture
|
3.8%
1/26 • Number of events 1 • Up to 36 months from procedure
|
0.00%
0/23 • Up to 36 months from procedure
|
|
Product Issues
Prosthetic Screw Loosening - Single
|
3.8%
1/26 • Number of events 1 • Up to 36 months from procedure
|
0.00%
0/23 • Up to 36 months from procedure
|
|
General disorders
Implant mobile/removed
|
0.00%
0/26 • Up to 36 months from procedure
|
4.3%
1/23 • Number of events 1 • Up to 36 months from procedure
|
|
General disorders
Cement - retained due to angle correction
|
3.8%
1/26 • Number of events 1 • Up to 36 months from procedure
|
0.00%
0/23 • Up to 36 months from procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place