Trial Outcomes & Findings for Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser (NCT NCT02357979)
NCT ID: NCT02357979
Last Updated: 2021-01-28
Results Overview
Difference in number of lesion changes into ICDAS score 3 (signifying a cavity) between matched case and control teeth (within patient) from baseline to 6 months and baseline to 12 months. The International Caries Detection and Assessment System (ICDAS) is a visual assessment of the caries levels. The ICDAS score ranges from 0 to 6, with score 0 meaning no demineralization at all, score 3 means a first physical loss of enamel, and score 6 means a huge cavity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 year
Results posted on
2021-01-28
Participant Flow
This study was performed between February 2018 and November 2019 at the University of California, San Francisco (UCSF) School of Dentistry.
Unit of analysis: 2nd molars-2/subject- 1-side L&F other F
Participant milestones
| Measure |
Laser & Fluoride
In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.
Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
|
Fluoride Alone
In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.
Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
|
|---|---|---|
|
Overall Study
STARTED
|
60 60
|
60 60
|
|
Overall Study
COMPLETED
|
55 55
|
55 55
|
|
Overall Study
NOT COMPLETED
|
5 5
|
5 5
|
Reasons for withdrawal
| Measure |
Laser & Fluoride
In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.
Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
|
Fluoride Alone
In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.
Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser
Baseline characteristics by cohort
| Measure |
Laser & Fluoride
n=60 right or left second molar
In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.
Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
|
Fluoride Alone
n=60 right or left second molar
In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.
Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
|
Total
n=120 right or left second molar
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13.1 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
13.1 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 right or left second molar
n=60 right or left second molar
|
0 right or left second molar
n=60 right or left second molar
|
0 right or left second molar
n=120 right or left second molar
|
|
Race (NIH/OMB)
Asian
|
16 right or left second molar
n=60 right or left second molar
|
16 right or left second molar
n=60 right or left second molar
|
32 right or left second molar
n=120 right or left second molar
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 right or left second molar
n=60 right or left second molar
|
0 right or left second molar
n=60 right or left second molar
|
0 right or left second molar
n=120 right or left second molar
|
|
Race (NIH/OMB)
Black or African American
|
9 right or left second molar
n=60 right or left second molar
|
9 right or left second molar
n=60 right or left second molar
|
18 right or left second molar
n=120 right or left second molar
|
|
Race (NIH/OMB)
White
|
31 right or left second molar
n=60 right or left second molar
|
31 right or left second molar
n=60 right or left second molar
|
62 right or left second molar
n=120 right or left second molar
|
|
Race (NIH/OMB)
More than one race
|
0 right or left second molar
n=60 right or left second molar
|
0 right or left second molar
n=60 right or left second molar
|
0 right or left second molar
n=120 right or left second molar
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 right or left second molar
n=60 right or left second molar
|
4 right or left second molar
n=60 right or left second molar
|
8 right or left second molar
n=120 right or left second molar
|
|
Region of Enrollment
United States
|
60 right or left second molar
n=60 right or left second molar
|
60 right or left second molar
n=60 right or left second molar
|
120 right or left second molar
n=120 right or left second molar
|
PRIMARY outcome
Timeframe: 1 yearDifference in number of lesion changes into ICDAS score 3 (signifying a cavity) between matched case and control teeth (within patient) from baseline to 6 months and baseline to 12 months. The International Caries Detection and Assessment System (ICDAS) is a visual assessment of the caries levels. The ICDAS score ranges from 0 to 6, with score 0 meaning no demineralization at all, score 3 means a first physical loss of enamel, and score 6 means a huge cavity.
Outcome measures
| Measure |
Laser & Fluoride
n=55 right or left second molar
In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.
Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
|
Fluoride Alone
n=55 right or left second molar
In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.
Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
|
|---|---|---|
|
International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity -
|
0 right or left second molar
|
13 right or left second molar
|
PRIMARY outcome
Timeframe: 1 yearDifferences in change in ICDAS scores between matched case and control teeth (within patient) from baseline to 6 months and baseline to 12 months. The International Caries Detection and Assessment System (ICDAS) is a visual assessment of the caries levels. The ICDAS score ranges from 0 to 6, with the score 0 meaning no demineralization at all, score 3 means a first physical loss of enamel, and score 6 means a huge cavity.
Outcome measures
| Measure |
Laser & Fluoride
n=51 right or left molar
In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.
Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
|
Fluoride Alone
n=51 right or left molar
In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.
Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
|
|---|---|---|
|
Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
ICDAS score change -1
|
4 right or left molar
|
0 right or left molar
|
|
Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
ICDAS score change 0
|
34 right or left molar
|
13 right or left molar
|
|
Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
ICDAS score change +1
|
12 right or left molar
|
28 right or left molar
|
|
Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
ICDAS score change +2
|
1 right or left molar
|
10 right or left molar
|
SECONDARY outcome
Timeframe: 1 yearDifferences in change in SOPROlife scores between matched case and control teeth (within patient) from baseline to 6 months and baseline to 12 month. The SOPROlife score (name of the intraoral camera system) is a visual assessment of the caries levels. The SOPROlife score ranges from 0 to 6, with score 0 meaning no demineralization at all, and score 6 means a huge cavity.
Outcome measures
| Measure |
Laser & Fluoride
n=52 right or left second molar
In the split mouth design the molar on one side of the mouth receives the intervention CO2 9.3 μm short pulsed laser treatment and fluoride varnish (experimental side) in the occlusal fissure areas.
Laser: CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
|
Fluoride Alone
n=51 right or left second molar
In the split mouth design this arm (this side in the mouth - the contralateral tooth to the experimental site in the same jaw) will receive only fluoride varnish treatment. In the split mouth design this opposite side of the jaw is functioning as control.
Fluoride: The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
|
|---|---|---|
|
Change in SOPROlife Scores
change -1
|
2 right or left second molar
|
0 right or left second molar
|
|
Change in SOPROlife Scores
change 0
|
47 right or left second molar
|
19 right or left second molar
|
|
Change in SOPROlife Scores
change +1
|
1 right or left second molar
|
30 right or left second molar
|
|
Change in SOPROlife Scores
change +2
|
2 right or left second molar
|
2 right or left second molar
|
Adverse Events
Laser & Fluoride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluoride Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Peter Rechmann
University of California at San Francisco
Phone: 415 514 3225
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place