Dental Caries
Conditions
Keywords
dental caries, vancomycin, chlorhexidine, sodium fluoride, mutans streptococci
Brief summary
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.
Detailed description
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.
Interventions
DRUGSodium Fluoride
Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
Sponsors
Universidade Federal do Ceara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy children * Children with at least one carious cavitated or non-cavitated lesion * Must be able to spit * Must be able to collaborate during clinical intervention
Exclusion criteria
* Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions * Children who underwent antibiotic treatment during the course of this clinical trial * Children with developmental disabilities * Children with no clinical signs dental caries
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of new carious lesions within the different study groups 12 months after treatment discontinuation. | one year |
Countries
Brazil
Outcome results
None listed