Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03089567 |
| Other study ID # |
SMAHEN |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2017 |
| Est. completion date |
January 15, 2018 |
Study information
| Verified date |
October 2020 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Comparison of the salivary levels of Streptococcus mutans in pediatric patients with Early
Childhood Caries after the application of Silver Diamine Fluoride or 5% Sodium Fluoride
Varnish
Description:
Dental caries is the most common chronic disease in children (Benjamin, 2010). Studies
suggest there is a positive correlation between bacterial titers of Streptococcus mutans and
dental caries (Pannu et. al., 2013). National surveys suggest children 2 to 5 years old have
27.90% of primary teeth with caries. This number near doubles to 51.17% for children 6 to 11
years old (United States, National Health and Nutrition Examination Survey, 1999-2004). The
American Academy of Pediatric Dentistry discusses this prevalence, in particular the finding
of caries in young children, calling it early childhood caries (ECC), defined as "the
presence of 1 or more decayed (noncavitated or cavitated lesions), missing (due to caries),
or filled tooth surfaces in any primary tooth in a child 71 months of age or younger" or
severe early childhood caries (S-ECC), defined as any sign of smooth surface caries in
children younger than three years of age (AAPD, 2008). Oral health disparities also vary by
race, ethnicity and socioeconomic status. Among children ages 3-5 years old, the prevalence
of dental caries was significantly higher for non-Hispanic black individuals, 19%, compared
to non-Hispanic white individuals, 11%. Furthermore, the prevalence of dental caries was
nearly twice as high for Hispanic individuals, 26%, compared to non-Hispanic white
individuals (Dye et. al., 2012).
The use of fluoride in dentistry has played a significant role in reducing the prevalence and
severity of dental caries. Water fluoridation is considered to be one of the ten greatest
achievements in public health of the twentieth century (CDC, 1999). Sodium Fluoride (SF)
varnishes have become a mainstay in many pediatric dental practices. Despite their intended
use as desensitizing agents, fluoride varnishes are used routinely to inhibit the
demineralization of enamel, promote remineralization of enamel, and arrest early enamel
carious lesions (Chu et. al, 2008, CDC 2001). Fluoride also interferes with cariogenic
bacteria's ability to metabolize carbohydrates, reducing their acid production, and ability
to adhere to tooth surfaces, possibly reducing their ability to initiate decay (CDC, 2001).
The ability of fluoride, namely SF varnishes to effect bacterial counts of S. mutans has been
described in a limited extent in the literature. Chandak describes fluoride varnish's ability
to reduce S. mutans counts in dental plaque, suggesting another way fluoride aids in the
reduction on dental caries (Chandak et. al., 2016). However, other studies do not support SF
varnishes abilities to significantly reduce plaque S. mutans counts (Sajjan, et. al., 2013).
Other studies attempt to examine the effects of fluoride varnishes' ability to effect S.
mutans adherence and biofilm formation. In their study Chau et. al, described a reduction in
S. mutans adhesion and subsequent biofilm accumulation in the presence of a number of
commercially available SF varnishes (Chau et. al, 2014).
Similar to fluoride compounds, the antimicrobial effects of silver containing compounds have
been used in dentistry for nearly a century. The mechanism behind these compounds'
antibacterial effect is derived from the bioactive silver ion's ability to disrupt and
irreversibly damage vital bacterial enzyme systems (Lansdown 2006). Despite their use
internationally since the early twentieth century, silver containing compounds have fallen
out of favor over time. More recently, silver diamine fluoride (SDF), currently approved by
the FDA for treatment of dentinal hypersensitivity, has been shown to possess caries
arresting properties. The clinical applications of SDF are seemly vast. Average operating
room (OR) wait times vary between providers and can range from days to months depending on
such factors as the provider's availability and resources, the patient's symptomatology,
medical history, and extent of treatment. The patient population served at the Yale-New Haven
Hospital Pediatric Dental Center is diverse both demographically and medically. Due to the
demand and need for comprehensive dental treatment under general anesthesia, average OR wait
times are 4 to 6 months. Indications for OR treatment include medically complex patients,
uncooperative or pre-cooperative behavior profiles, patients with extensive and
multi-quadrant decay patterns, and patients who do not meet selection criteria for sedation
modalities. SDF's ability to arrest dental decay allows for patients on lengthy wait list
awaiting treatment in the OR to avoid having their caries progress significantly. SDF is not
a solution to caries; however it can be a useful tool in stemming the progression of decay
for children awaiting surgical intervention under general anesthesia.
In light of SDF's ability to arrest dental caries, there is a question about its ability to
impact the etiology of caries initiation, namely its effect on salivary S. mutans counts in
the oral cavity. Few studies have investigated SDF's ability to alter bacterial counts in the
oral environment in children. The application of SDF to human dentin blocks resulted in the
development of fewer colony forming units of a number of cariogenic bacteria, including S.
mutans, compared to the control group (Mei, 2013). Similar results were described in a study
examining the effect of silver fluoride on S. mutans biofilm formation (Knight et. al.,
2009). The impact of such an effect would be profound and could change caries management and
prevention in the pediatric population (Duangthip, Chu et. al. 2016).
The increased interest and popularity of SDF has the potential to change the manner in which
dental caries are treated in the pediatric population. Applications can prevent more invasive
and costly need for general anesthesia, or other advanced behavior management techniques, or
possibly prevent the progression of decay and avoid the loss of teeth (Chu, 2000).
Furthermore, the potential ability of SDF to affect the bacterial composition of the oral
environment, possibly reducing the initiation of caries has the exciting potential to be a
ground breaking public health achievement.
Hypothesis
Application of SDF on carious teeth will show a higher decrease the salivary bacterial counts
of S. mutans form baseline in 2-6 years old patients with ECC when compared to S. mutans
levels after sodium fluoride varnish application and no treatment
Preliminary Research Design
Patient selection: Healthy 2-6 years old patients with ECC awaiting comprehensive dental
treatment under general anesthesia
Inclusion criteria: ASA I without prior history of dental restorations
Exclusion criteria: Patient with: special healthcare needs, xerostomia, complicated medical
history (ASA II-VI)
Experimental Groups:
- 30 Patients that will receive 38% SDF application
- 30 Patients that will receive 5% NaF varnish application
- 30 Patient in Control group that will receive no treatment
Salivary collection: Salivary samples will be collected with SalivaBio Children's Swab.
A baseline S. mutans level will be obtained and quantified using Saliva-Check Mutans (GC
America).
All carious teeth will receive a rubber cup and paste dental prophylaxis followed by either a
topical application of 38% SDF, or 5% NaF varnish or no topical treatment.
Follow up: Further measurement of S. mutans levels will be obtained at 1, 3, 6 months after
initial SDF, NaF varnish applications no treatment, without dental prophylaxis. Following
salivary sample collections, re-application of SDF and NaF varnish will be applied to
appropriate patient groups, and no further treatment provided to control group.
