Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser
NCT ID: NCT02357979
Last Updated: 2021-01-28
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-08
Study Completion Date
2020-03-31
Brief Summary
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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.
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Detailed Description
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The study is designed as randomized, single blind, prospective, split mouth controlled, clinical trial over 12 months. The subjects for this study will be recruited from the UCSF School of Dentistry. Patients meeting the inclusion criteria from the UCSF Predoctoral, Postgraduate Pediatric Dental and Postgraduate orthodontic clinics will have the study explained to them and be invited to participate.
Young patients with moderate/high caries risk will be invited to enroll into the study. They will have to have a pair of two molars which have not been treated so far and are caries free and not sealed. The molar on patient's dominant side (right or left) will be randomly assigned to either the test or the control group with the contralateral non-dominant side receiving the other treatment. The test tooth will be treated with CO2 laser irradiation and fluoride varnish; the control tooth will receive fluoride varnish treatment alone.
A baseline visual inspection using ICDAS II, white and blue light digital photographs (SOPROLIFE), and DIAGNOdent assessments will be made by a dentist prior to treatment.
The patient will be asked to return for a 6-month and a 12-month follow up exam, at which time visual inspection with all testing methods will be conducted by the dentist who originally completed the baseline exam. The endpoint of the study for each participant will be when either the control or test tooth is found to have significant demineralization by ICDAS assessment (ICDAS code 3 - "localized enamel breakdown without clinical visual signs of dentinal involvement") or at the 12 month exam, whichever comes first.
The control and test teeth might be sealed with a dental sealant at the end of the study. All data obtained will be analyzed for statistical significance.
Young patients with moderate/high caries risk will be invited to enroll into the study. They will have to have a pair of two molars which have not been treated so far and are caries free and not sealed. The molar on patient's dominant side (right or left) will be randomly assigned to either the test or the control group with the contralateral non-dominant side receiving the other treatment. The test tooth will be treated with CO2 laser irradiation and fluoride varnish; the control tooth will receive fluoride varnish treatment alone.
A baseline visual inspection using ICDAS II, white and blue light digital photographs (SOPROLIFE), and DIAGNOdent assessments will be made by a dentist prior to treatment.
The patient will be asked to return for a 6-month and a 12-month follow up exam, at which time visual inspection with all testing methods will be conducted by the dentist who originally completed the baseline exam. The endpoint of the study for each participant will be when either the control or test tooth is found to have significant demineralization by ICDAS assessment (ICDAS code 3 - "localized enamel breakdown without clinical visual signs of dentinal involvement") or at the 12 month exam, whichever comes first.
The control and test teeth might be sealed with a dental sealant at the end of the study. All data obtained will be analyzed for statistical significance.
Conditions
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Dental Caries
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Investigators
Study Groups
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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.
Group Type
EXPERIMENTAL
Laser
Intervention Type
DEVICE
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.
Group Type
ACTIVE_COMPARATOR
Fluoride
Intervention Type
OTHER
The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
Interventions
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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.
Intervention Type
DEVICE
Fluoride
The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
Intervention Type
OTHER
Other Intervention Names
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Convergent Solea CO2 laser
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
6 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Peter Rechmann, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF School of Dentistry - Dental Offices in Bay Area
San Francisco, California, United States
Site Status
Countries
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United States
References
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BACKGROUND
Rechmann P, Kubitz M, Chaffee BW, Rechmann BMT. Fissure caries inhibition with a CO2 9.3-mum short-pulsed laser-a randomized, single-blind, split-mouth controlled, 1-year clinical trial. Clin Oral Investig. 2021 Apr;25(4):2055-2068. doi: 10.1007/s00784-020-03515-x. Epub 2020 Aug 15.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LaserFissure-1st
Identifier Type: -
Identifier Source: org_study_id
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