Clinical Trial Proximal Caries Infiltration and Detection

Objective: The hypothesis to be tested is that Icon performs similarly to an established
prevention strategy for early caries (Oral hygiene instruction and topical fluoridation) for
caries arrest; and caries progression may be imaged through a SFE laser optical device.

Materials and Methods: The investigators propose a pilot study of Icon vs. control including
Oral Hygiene Instructions (OHI) and topical fluoridation for early caries arrest in primary
molars. Lesion depth will be performed through standard-of care methods, i.e. radiographs and
visual exams, plus a novel optical device based on scanning fiber endoscope (SFE) technology
for laser light imaging for early caries detection in pediatric populations. The
investigators will utilize SFE laser optical device prototypes developed by the University of
Washington's Human Photonics Lab (HPL), a device already in human use for other applications,
including imaging and cancer screening.

Clinical Significance: This controlled trial will assess the positive effects of white spot
infiltration by ICON and may open a new therapeutic strategy in paediatric dentistry.
Additionally, this study would be one of the first in vivo dental applications of the SFE
optical device, and would add a novel early caries visualization technique to the
armamentarium for detecting caries progression.

Inclusion Criteria:

- Children in age from 6-13 years

- minimum of 2 early caries lesions present in primary molars

Criteria used to assess teeth for acceptance into this study include:

1. teeth fully erupted, in functional occlusion and

2. radiographic evidence of early caries in interproximal areas - good general health and
free of any systemic disease or disability

Exclusion Criteria:

- when currently enrolled in a study that includes evaluation of other restorative
materials or systems involving posterior teeth

- documented history of any adverse reaction to clinical materials

- Patients refusing radiograph exam

- pregnancy