Trial Outcomes & Findings for Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study (NCT NCT03100435)
NCT ID: NCT03100435
Last Updated: 2023-03-31
Results Overview
Percent area of the titanium disc covered by bacteria biofilm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
3 days
Results posted on
2023-03-31
Participant Flow
From May 2017 to August 2018, 8 enrollments were made in the Department of Periodontology at Tufts University School of Dental Medicine
Each subject participates in each arm, as 2 titanium discs from each subject are distributed among all 4 arms.
Unit of analysis: 2 titanium disks per enrollee per arm
Participant milestones
| Measure |
All Study Participants
Each participant provides 2 Titanium disks that are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curette, with titanium brush, or not decontaminated.
|
|---|---|
|
Overall Study
STARTED
|
8 64
|
|
Overall Study
YAG Laser
|
8 16
|
|
Overall Study
Carbon Fiber Curette
|
8 16
|
|
Overall Study
Titanium Brush
|
8 16
|
|
Overall Study
Not Decontaminated
|
8 16
|
|
Overall Study
COMPLETED
|
8 59
|
|
Overall Study
NOT COMPLETED
|
0 5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=8 Participants
Titanium disks are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curettes, with titanium brush, or are not decontaminated .
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: From 64 collected titanium disks, 5 were removed from analysis. 4 disks were dislodged from 2 enrolled participants and 1 disk was excluded due to improper magnification of the SYTO 9 imaging.
Percent area of the titanium disc covered by bacteria biofilm
Outcome measures
| Measure |
Laser
n=8 Participants
Titanium disks are decontaminated ex-vivo with the Er:YAG laser.
|
Curette
n=8 Participants
Titanium disks are decontaminated ex-vivo with carbon fiber curettes
|
Brush
n=8 Participants
Titanium disks are decontaminated ex-vivo with titanium brush
|
Control
n=14 Titanium disks
Titanium disks are not decontaminated
|
|---|---|---|---|---|
|
Percent Bacteria Biofilm
|
32.78 percentage of disc covered
Standard Deviation 24
|
20.14 percentage of disc covered
Standard Deviation 19.15
|
11.8 percentage of disc covered
Standard Deviation 10.29
|
74.03 percentage of disc covered
Standard Deviation 21.61
|
Adverse Events
Er:YAG Laser
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Carbon Fiber Curette
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Er:YAG Laser + Carbon Fiber Curette
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Er:YAG Laser
n=8 participants at risk
Er:YAG Laser only
Er:YAG Laser: Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.
|
Carbon Fiber Curette
n=8 participants at risk
Carbon fiber curette only
Carbon Fiber Curette: Titanium disks will be decontaminated ex-vivo with carbon fiber curettes
|
Er:YAG Laser + Carbon Fiber Curette
n=8 participants at risk
Combination of Er:YAG Laser and carbon fiber curette
Er:YAG Laser: Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.
Carbon Fiber Curette: Titanium disks will be decontaminated ex-vivo with carbon fiber curettes
|
No Treatment
n=8 participants at risk
No treatment (control)
|
|---|---|---|---|---|
|
Product Issues
Titanium disc dislodged from appliance
|
25.0%
2/8 • Number of events 2 • 3 days (the duration of wearing the intraoral appliance)
|
25.0%
2/8 • Number of events 2 • 3 days (the duration of wearing the intraoral appliance)
|
25.0%
2/8 • Number of events 2 • 3 days (the duration of wearing the intraoral appliance)
|
25.0%
2/8 • Number of events 2 • 3 days (the duration of wearing the intraoral appliance)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place