Dental CariesLaserFissureNCT02357979
Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser
A study testing Laser and Fluoride in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Laser and Fluoride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF School of Dentistry - Dental Offices in Bay Area
San Francisco, California, 94143
About this study
Official title: Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser - A Randomized, Single Blind, Prospective, Split Mouth Controlled, Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Dental Caries
- Being tested
- Laser, Fluoride
- Keywords
- caries, prevention, laser, fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Also called Convergent Solea CO2 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.
FluorideOther
The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
| Study group | Role | What they receive |
|---|---|---|
| Laser & Fluoride | Experimental | 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. Receives: Device: Laser |
| Fluoride alone | Active comparator | 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. Receives: Other: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity -
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.
Measured: 1 year
Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
Differences 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.
Measured: 1 year
Secondary outcomes (1)
Change in SOPROlife Scores
Differences 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start8 Feb 2018
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rechmann, DDS, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357979
- Sponsor's protocol ID
- LaserFissure-1st
- Acronym
- LaserFissure
- Status last verified
- Jan 2021
- First submitted
- 3 Feb 2015
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Beltran-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.
PubMed 16121123Brown LJ, Kaste LM, Selwitz RH, Furman LJ. Dental caries and sealant usage in U.S. children, 1988-1991: selected findings from the Third National Health and Nutrition Examination Survey. J Am Dent Assoc. 1996 Mar;127(3):335-43. doi: 10.14219/jada.archive.1996.0203.
PubMed 8819780Lussi A. Validity of diagnostic and treatment decisions of fissure caries. Caries Res. 1991;25(4):296-303. doi: 10.1159/000261380.
PubMed 1913769Featherstone JD. Caries detection and prevention with laser energy. Dent Clin North Am. 2000 Oct;44(4):955-69, ix.
PubMed 11048282Pitts NB. How the detection, assessment, diagnosis and monitoring of caries integrate with personalized caries management. Monogr Oral Sci. 2009;21:1-14. doi: 10.1159/000224208. Epub 2009 Jun 3.
PubMed 19494672Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963de Josselin de Jong E, Sundstrom F, Westerling H, Tranaeus S, ten Bosch JJ, Angmar-Mansson B. A new method for in vivo quantification of changes in initial enamel caries with laser fluorescence. Caries Res. 1995;29(1):2-7. doi: 10.1159/000262032.
PubMed 7867045Al-Khateeb S, Forsberg CM, de Josselin de Jong E, Angmar-Mansson B. A longitudinal laser fluorescence study of white spot lesions in orthodontic patients. Am J Orthod Dentofacial Orthop. 1998 Jun;113(6):595-602. doi: 10.1016/s0889-5406(98)70218-5.
PubMed 9637561Tranaeus S, Al-Khateeb S, Bjorkman S, Twetman S, Angmar-Mansson B. Application of quantitative light-induced fluorescence to monitor incipient lesions in caries-active children. A comparative study of remineralisation by fluoride varnish and professional cleaning. Eur J Oral Sci. 2001 Apr;109(2):71-5. doi: 10.1034/j.1600-0722.2001.00997.x.
PubMed 11347658Tranaeus S, Shi XQ, Lindgren LE, Trollsas K, Angmar-Mansson B. In vivo repeatability and reproducibility of the quantitative light-induced fluorescence method. Caries Res. 2002 Jan-Feb;36(1):3-9. doi: 10.1159/000057583.
PubMed 11961323Pretty IA, Ellwood RP. Comparison of paired visual assessment and software analyses of changes in caries status over 6 months from fluorescence images. Caries Res. 2007;41(2):115-20. doi: 10.1159/000098044.
PubMed 17284912Yin W, Feng Y, Hu D, Ellwood RP, Pretty IA. Reliability of quantitative laser fluorescence analysis of smooth surface lesions adjacent to the gingival tissues. Caries Res. 2007;41(3):186-9. doi: 10.1159/000099316.
PubMed 17426397Rocha RO, Ardenghi TM, Oliveira LB, Rodrigues CR, Ciamponi AL. In vivo effectiveness of laser fluorescence compared to visual inspection and radiography for the detection of occlusal caries in primary teeth. Caries Res. 2003 Nov-Dec;37(6):437-41. doi: 10.1159/000073396.
PubMed 14571122Astvaldsdottir A, Holbrook WP, Tranaeus S. Consistency of DIAGNOdent instruments for clinical assessment of fissure caries. Acta Odontol Scand. 2004 Aug;62(4):193-8. doi: 10.1080/00016350410001612.
PubMed 15513415
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser - A Randomized, Single Blind, Prospective, Split Mouth Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02357979
- Acronym / sponsor ID
- LaserFissure / LaserFissure-1st
- Conditions
- Dental Caries
- Keywords
- caries, prevention, laser, fluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser & Fluoride | Experimental | Device: LaserIn 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. |
| Fluoride alone | Active comparator | Other: FluorideIn 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserAlso: Convergent Solea CO2 laserCO2 - 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. | Device | Laser & Fluoride |
| FluorideThe Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant. | Other | Fluoride alone |
Primary outcome
International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity -
Time frame: 1 year
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.
Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
Time frame: 1 year
Differences 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.
1 secondary outcome
Change in SOPROlife Scores
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23295957Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Background: PubMed 16121123Beltran-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.
- Background: PubMed 8819780Brown LJ, Kaste LM, Selwitz RH, Furman LJ. Dental caries and sealant usage in U.S. children, 1988-1991: selected findings from the Third National Health and Nutrition Examination Survey. J Am Dent Assoc. 1996 Mar;127(3):335-43. doi: 10.14219/jada.archive.1996.0203.
- Background: PubMed 1913769Lussi A. Validity of diagnostic and treatment decisions of fissure caries. Caries Res. 1991;25(4):296-303. doi: 10.1159/000261380.
- Background: PubMed 11048282Featherstone JD. Caries detection and prevention with laser energy. Dent Clin North Am. 2000 Oct;44(4):955-69, ix.
- Background: PubMed 19494672Pitts NB. How the detection, assessment, diagnosis and monitoring of caries integrate with personalized caries management. Monogr Oral Sci. 2009;21:1-14. doi: 10.1159/000224208. Epub 2009 Jun 3.
- Background: PubMed 17518963Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
- Background: PubMed 7867045de Josselin de Jong E, Sundstrom F, Westerling H, Tranaeus S, ten Bosch JJ, Angmar-Mansson B. A new method for in vivo quantification of changes in initial enamel caries with laser fluorescence. Caries Res. 1995;29(1):2-7. doi: 10.1159/000262032.
- Background: PubMed 9637561Al-Khateeb S, Forsberg CM, de Josselin de Jong E, Angmar-Mansson B. A longitudinal laser fluorescence study of white spot lesions in orthodontic patients. Am J Orthod Dentofacial Orthop. 1998 Jun;113(6):595-602. doi: 10.1016/s0889-5406(98)70218-5.
- Background: PubMed 11347658Tranaeus S, Al-Khateeb S, Bjorkman S, Twetman S, Angmar-Mansson B. Application of quantitative light-induced fluorescence to monitor incipient lesions in caries-active children. A comparative study of remineralisation by fluoride varnish and professional cleaning. Eur J Oral Sci. 2001 Apr;109(2):71-5. doi: 10.1034/j.1600-0722.2001.00997.x.
- Background: PubMed 11961323Tranaeus S, Shi XQ, Lindgren LE, Trollsas K, Angmar-Mansson B. In vivo repeatability and reproducibility of the quantitative light-induced fluorescence method. Caries Res. 2002 Jan-Feb;36(1):3-9. doi: 10.1159/000057583.
- Background: PubMed 17284912Pretty IA, Ellwood RP. Comparison of paired visual assessment and software analyses of changes in caries status over 6 months from fluorescence images. Caries Res. 2007;41(2):115-20. doi: 10.1159/000098044.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rechmann, DDS, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Fluoride in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity - (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357979, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.