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

Dental Caries Clinical Trial

Official title: Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser - A Randomized, Single Blind, Prospective, Split Mouth Controlled, Clinical Trial

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dental Caries

• NCT number: NCT02357979
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Completion date: March 31, 2020