Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride

Interproximal carious lesions are challenging to control and arrest due to difficulty
reaching the contact area (in between teeth), limited salivary access, and poor flossing
compliance in children and adolescents when flossing themselves. The vast majority of caries
observed in children ages 5 to 10 are on interproximal surfaces.

Silver diamine fluoride (SDF) is a topical medicament touted as a very safe and noninvasive
alternative and/or adjunct to topical fluoride treatment or restorative treatment to halt the
progress ("arrest") of caries. SDF has been shown to remineralize ("reverse") demineralized
enamel or dentin, inhibit collagenases to protect dentin collagen from destruction, and have
bactericidal properties to cariogenic bacteria including streptococcus mutans. Normally, SDF
is applied with a microbrush directly on an exposed carious lesion, but due to difficulty
reaching interproximal carious lesions, an absorbent type of floss such as Super Floss has
been proposed as a delivery method for SDF application.

The purpose of this study is to investigate whether 1) SDF application using Super Floss can
arrest and/or reverse initial interproximal caries on primary molars and 2) whether SDF
applied with Super Floss is more effective in arresting or remineralizing initial
interproximal lesion in comparison to SDF applied without Super Floss or Fluoride varnish
applied alone.

The study population includes healthy children, aged 3-12, with initial interproximal decay
on deciduous molars identified by radiographs. In this study, initial decay is defined as
radiographic decay within enamel or extending to the dentin-enamel junction based on
International Caries Classification and Management System (ICCMS). Any eligible participant
will be randomly allocated to one of three treatments: Fluoride varnish (Control) application
alone versus SDF application without Super Floss (Control) versus SDF application with Super
Floss (Intervention), which will be applied at the initial visit. At 3, 6, and 12 months, the
participants will return for reapplication of their respective treatments. At the 6 month and
12 month mark, bitewing radiographs will be taken to determine status of the interested
lesion(s). If a lesion progresses beyond the outer 1/3 of dentin, then the patient will be
withdrawn and recommended routine restorative dental treatment. If a lesion arrests or
reverses, then the current treatment will continue until end of study duration (12 months)
and re-evaluated.

A statistician will be assisting us with descriptive statistics, cluster-adjusted chi-squared
test, and other statistics to determine if any correlation exists.

Inclusion Criteria:

- ASA I and ASA II children, aged 3-12

- Behavior of 3 or 4 on Frankl scale

- Radiographic decay within enamel or extending to the dentin-enamel junction based on
International Caries Classification and Management System (ICCMS) Categories 1, 2 and
3 "Initial stages".

- Target interproximal lesion does not have existing restoration, recurrent decay, or
adjacent teeth with existing restorations.

Exclusion Criteria:

- Children who are not ASA I or ASA II

- Children who are allergic to or intolerant of SDF

- Children who have known sensitivity to silver or heavy metal-ions, or have abnormal
skin sensitization.

- Children who have ulcerative gingivitis or stomatitis.

- Carious interproximal lesions on primary molars in ICCMS Category 4, 5, or 6 18 ,
which signify the extent of the carious lesion radiographically reaching the middle
1/3 of dentin, inner 1/3 of dentin, and into the pulp respectively.

- Behavior of a child within the Frankl 1 or 2 category, indicating a "Definitely
Negative" and "Negative" behavior, which may compromise safe application of SDF.