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The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.
The present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th day (D30). For microbiological analysis, MSB agar medium was used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaF | Placebo Comparator | Sodium fluoride application |
|
| V3 | Experimental | Topical application of 3% vancomycin |
|
| V10 | Experimental | Topical application of 10% vancomycin |
|
| CHX | Active Comparator | Topical application of 1% chlorhexidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Fluoride | Drug | Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1. | 30-day observational period for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Number of new carious lesions within the different study groups 12 months after treatment discontinuation. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane SR Fonteles, DDS, MS, PhD | Federal University of Ceará | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara | Fortaleza | Ceará | 60441-750 | Brazil |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| D014640 | Vancomycin |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| vancomycin hydrochloride | Drug | Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days |
|
|
| vancomycin hydrochloride | Drug | Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days |
|
|
| chlorhexidine digluconate | Drug | Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days |
|
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |