Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser

NCT02357979 | Completed Results FDA Device

• 1 other identifier: LaserFissure-1st
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

caries; prevention; laser; fluoride

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in SOPROlife Scores

  1 year

Study Arms (2)

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.

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.

Other: Fluoride

Interventions

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.

Also known as: Convergent Solea CO2 laser

Laser & Fluoride

Fluoride OTHER

The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.

Fluoride alone

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF School of Dentistry - Dental Offices in Bay Area

San Francisco, California, 94143, United States

Location

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MeSH Terms

Conditions

Dental Caries

Interventions

Lasers; Fluorides

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Results Point of Contact

• Title: Dr. Peter Rechmann
• Organization: University of California at San Francisco

Peter.Rechmann@ucsf.edu

415 514 3225

Study Officials

• Peter Rechmann, DDS, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: February 8, 2018
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: January 28, 2021
• Results First Posted: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)