Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial
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The main purpose of this split month, randomized, controlled clinical trial was evaluate the efficacy of caries infiltration in controlling the progression of non-cavitated proximal lesions in primary molars. Anxiety and time required for the caries infiltration was also evaluated.
Materials and methods
Fifty healthy children, 5 to 9 years, presenting two primary molars with proximal caries lesions (1/2 of the enamel or outer 1/3 of dentin), were included. Lesions were randomly allocated to the test group (fluoridated toothpaste + flossing + infiltration) or to the control group (fluoridated toothpaste + flossing). Caries risk was based on the Cariogram model. The main outcome after 1-year radiographic follow up was assessed by an independent blinded examiner A facial image scale (FIS) was applied to assess dental anxiety and time required to perform the infiltration was recorded.
Of the sample, 92.9% corresponded to high or medium caries risk. In 42 patients (1-year follow up), caries progression was observed in 11.9% (5/42) of the test lesions compared with 33.3% (14/42) of the control lesions (p < 0.05). Five control and three test lesions progressed to the middle 1/3 of dentin and were restored. No side effects were observed. Anxiety was both low before and after the treatment, and mean time required for the infiltration was 11.29 min (± 1.16 min).
Caries infiltration of proximal caries lesions in primary molars is significantly more efficacious than standard therapy alone (fluoride toothpaste + flossing).
Caries infiltration is an applicable and well-accepted method be used in children, representing a promising micro-invasive approach.
KeywordsPrimary molars Proximal lesions Caries infiltration Radiography Clinical trials Efficacy
The work was supported by FAPERJ no. E-26/110.273/2012 and DMG.
Compliance with ethical standards
Conflict of interest
Authors RCJ and IPRS declare no conflict of interest. Authors MMA and VMS received research grant from DMG, Hamburg, Germany. The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Ethics approval and consent to participate
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
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