Trial Outcomes & Findings for Immediate Loading and Fully Guided Surgery: Single Implants (NCT NCT04061694)
NCT ID: NCT04061694
Last Updated: 2020-03-31
Results Overview
Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
12 months
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Digital Immediate Loading
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
25
|
|
Overall Study
COMPLETED
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Digital Immediate Loading
n=21 Participants
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 Participants
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 21.0 • n=21 Participants
|
40.8 years
STANDARD_DEVIATION 13.3 • n=25 Participants
|
40.5 years
STANDARD_DEVIATION 17.0 • n=46 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=21 Participants
|
11 Participants
n=25 Participants
|
21 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=21 Participants
|
14 Participants
n=25 Participants
|
25 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
21 participants
n=21 Participants
|
25 participants
n=25 Participants
|
46 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSurvival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction
Outcome measures
| Measure |
Digital Immediate Loading
n=21 Participants
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 Participants
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
Number of Participants With Implant Survival
|
19 participants
|
25 participants
|
PRIMARY outcome
Timeframe: 12 monthsMarginal bone loss MBL, measured in mm from implant abutment junction.
Outcome measures
| Measure |
Digital Immediate Loading
n=19 Participants
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 Participants
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
MBL
|
-0.40 mm
Standard Deviation 0.41
|
-0.57 mm
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: 12 monthsPink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.
Outcome measures
| Measure |
Digital Immediate Loading
n=19 Participants
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 Participants
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
Pink Esthetic Score
|
10.53 score on a scale
Standard Deviation 2.04
|
10.36 score on a scale
Standard Deviation 2.46
|
PRIMARY outcome
Timeframe: 12 monthsWhite Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.
Outcome measures
| Measure |
Digital Immediate Loading
n=19 Participants
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 Participants
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
White Esthetic Score
|
7.79 score on a scale
Standard Deviation 1.36
|
7.76 score on a scale
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: 12 monthsOral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.
Outcome measures
| Measure |
Digital Immediate Loading
n=19 Participants
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 Participants
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
Oral Health Impact Profile - 14
|
17.10 score on a scale
Standard Deviation 3.23
|
16.48 score on a scale
Standard Deviation 3.87
|
Adverse Events
Digital Immediate Loading
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Loading
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Digital Immediate Loading
n=21 participants at risk
Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing
Immediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
|
Immediate Loading
n=25 participants at risk
Immediate loading: Only subjected to immediate loading. Conventional procedure.
|
|---|---|---|
|
Surgical and medical procedures
Dental implant loss
|
9.5%
2/21 • 1 year
Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.
|
0.00%
0/25 • 1 year
Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place