N/A
N=120
Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02357979 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity - — 0; 13 right or left second molar
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laser (Device); Fluoride (Other)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity - |
0; 13 | — |
| PRIMARY Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) - |
4; 0; 34; 13; 12; 28 | — |
| SECONDARY Change in SOPROlife Scores |
2; 0; 47; 19; 1; 30 | — |
Summary
The objective of this clinical study is to evaluate whether the use of the new CO2 - 9.3μm short-pulsed laser increases the caries resistance of occlusal pit and fissure surfaces in patients in addition to fluoride therapy. This will be quantified by visual exams with the International Caries Detection and Assessment System (ICDAS II), SOPROLIFE daylight and blue fluorescence, and DIAGNOdent Laser Light-induced Fluorescence. This is a randomized, single blind, prospective, split mouth controlled, clinical trial over 12 months.
Eligibility Criteria
Inclusion Criteria
- age 6 or older, in good general health
- subject is of moderate or high caries risk according to CAMBRA
- has at least one pair of unsealed molars in at least one jaw with need for a sealant
- teeth with an ICDAS code 0, 1 and 2 with deep grooves and fissures providing an anatomical stick for an explorer
- willing to comply with all study procedures and protocols
- must be able to read and understand English
- have an understanding of the study
- residing in San Francisco or other nearby locales with community water fluoridation (to eliminate water fluoridation as a potential confounding variable)
- patient and parent/guardian able to provide written informed consent in English
- willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research.
Exclusion Criteria
- show evidence of extremely poor oral hygiene
- subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis),
- taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia [extreme high caries risk])
- other conditions that may decrease the likelihood of adhering to study protocol
- subjects who will leave the area and are unable to complete the study
Data sourced from ClinicalTrials.gov (NCT02357979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.