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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rechmann, DDS, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF School of Dentistry - Dental Offices in Bay Area | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23295957 | Background | 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. | |
| 16121123 |
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This study was performed between February 2018 and November 2019 at the University of California, San Francisco (UCSF) School of Dentistry.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Each participant had to provide a cavity free pair of second molars (right and left second molar in one jaw (upper or lower jaw) - only ICDAS scores 0, 1 and 2 were allowed at baseline for these teeth.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Units | right or left second molar | No | 1 year | right or left second molar | right or left second molar |
|
Adverse event data were collected from enrollment through one year follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Rechmann | University of California at San Francisco | 415 514 3225 | Peter.Rechmann@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2015 | Dec 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D000838 | Anions |
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|
|
| Fluoride | Other | The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant. |
|
| 1 year |
| Background |
| Beltran-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. |
| 8819780 | Background | Brown 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. |
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| 15513415 | Background | Astvaldsdottir 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. |
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| 16251794 | Background | Angnes V, Angnes G, Batisttella M, Grande RH, Loguercio AD, Reis A. Clinical effectiveness of laser fluorescence, visual inspection and radiography in the detection of occlusal caries. Caries Res. 2005 Nov-Dec;39(6):490-5. doi: 10.1159/000088185. |
| 15970371 | Background | Reis A, Mendes FM, Angnes V, Angnes G, Grande RH, Loguercio AD. Performance of methods of occlusal caries detection in permanent teeth under clinical and laboratory conditions. J Dent. 2006 Feb;34(2):89-96. doi: 10.1016/j.jdent.2005.04.002. Epub 2005 Jun 20. |
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| 22953601 | Background | Rechmann P, Rechmann BM, Featherstone JD. Caries detection using light-based diagnostic tools. Compend Contin Educ Dent. 2012 Sep;33(8):582-4, 586, 588-93; quiz 594, 596. |
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| 1423438 | Background | Hafstrom-Bjorkman U, Sundstrom F, de Josselin de Jong E, Oliveby A, Angmar-Mansson B. Comparison of laser fluorescence and longitudinal microradiography for quantitative assessment of in vitro enamel caries. Caries Res. 1992;26(4):241-7. doi: 10.1159/000261446. |
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| 9470510 | Background | al-Khateeb S, ten Cate JM, Angmar-Mansson B, de Josselin de Jong E, Sundstrom G, Exterkate RA, Oliveby A. Quantification of formation and remineralization of artificial enamel lesions with a new portable fluorescence device. Adv Dent Res. 1997 Nov;11(4):502-6. doi: 10.1177/08959374970110041801. |
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| 3125842 | Background | Featherstone JD, Nelson DG. Laser effects on dental hard tissues. Adv Dent Res. 1987 Oct;1(1):21-6. doi: 10.1177/08959374870010010701. No abstract available. |
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| 32803438 | Derived | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| right or left second molar |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Units | right or left second molar | right or left second molar |
|
| Region of Enrollment | Number | right or left second molar | right or left second molar |
|
| OG001 | 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. |
|
|
| Primary | 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. | Posted | Count of Units | right or left molar | 1 year | right or left molar | right or left molar |
|
|
|
| Secondary | 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. | Posted | Count of Units | right or left second molar | 1 year | right or left second molar | right or left second molar |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D007477 |
| Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| ICDAS score change +1 |
|
| ICDAS score change +2 |
|
| change +1 |
|
| change +2 |
|