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2016 ; 16
(1
): 102
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A randomized, double-blind, placebo-controlled clinical trial of fluoride varnish
in preventing dental caries of Sjögren s syndrome patients
#MMPMID27664129
Xin W
; Leung KC
; Lo EC
; Mok MY
; Leung MH
BMC Oral Health
2016[Sep]; 16
(1
): 102
PMID27664129
show ga
BACKGROUND: Sjögren's syndrome (SS) patients are prone to caries development due
to reduction of salivary flow. Topical fluoride is commonly prescribed for caries
prevention. METHODS: In this 24-month randomized, double-blind,
placebo-controlled clinical trial, SS patients were randomly assigned to receive
either fluoride varnish or placebo gel quarterly. Development and arrest of
caries at the coronal and root surfaces were recorded at 12-month and 24-month
and compared to that of the baseline. Effect of fluoride varnish on oral Candida
and lactobacilli colonization was explored by comparing baseline oral
microbiological assessments to data obtained at 12-month and 24-month. RESULTS:
Seventy-eight SS patients (mean age?=?50 years, 2 men) completed this trial. At
24-month, the mean new coronal enamel caries were 1.6 surfaces in both groups,
and new dentin caries were 1.4 and 2.7 surfaces in the fluoride and placebo group
respectively (p?>?0.05). Mean arrested caries were 0.6 and 0.7 surfaces for
fluoride and placebo groups respectively and that of root caries were 0.3 and 0.1
surfaces (p?>?0.05). The mean oral Candida count was reduced by 30 % in the
fluoride group but increased 61 % in the placebo group while no change in oral
lactobacilli counts in both groups at 24 months (p?>?0.05). SS patients receiving
fluoride varnish were significantly less likely to develop dentin caries
(p?0.05). In contrast, those with high baseline DMFS scores (p?=?0.05),
harbored mixed Candida species (p?0.05), or unstimulated whole saliva at low pH
(p?0.01) were significantly more likely to develop dentin caries. CONCLUSIONS:
Results of this randomized clinical trial did not provide clear evidence to
support or refute that quarterly applications of fluoride varnish can prevent
development of dental caries in people with Sjögren's syndrome. TRIAL
REGISTRATION: This study was retrospectively registered at the ISRCTN registry (
ISRCTN85164658 ) on 9 Sept 2016 and was funded by the Research Grant Council of
Hong Kong.