Conditions: Dental Caries
Keywords: Streptococcus Mutans Saliva
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: yes

Brief summary:
This study compared four mouth rinses/chews for their ability to reduce Streptococcus Mutans after usage. The four that were compared were chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar free), and deionized water. The paraffin wax chewing gum replaced the originally planned coconut oil and served as a placebo comparator.

Detailed description:
The study was a randomized controlled clinical trial, unblinded. After obtaining consent and assent, respectively, and following review of medical history with regard to inclusion/exclusion criteria, if the participant met eligibility criteria, the participant was randomly assigned to one of four groups being studied: chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar-free) or deionized water with a randomization ratio of 1:1:1:1. A pre rinse/chew salivary sample was obtained by having the participant spit into a sterile test tube. The participant then either rinsed with 10mL of the assigned rinse for a timed 30 seconds and expectorated, or chewed paraffin wax chewing gum for 2 minutes. A post rinse/chew salivary sample was taken similarly to the pre rinse/chew sample. The samples were transported to a microbiology lab for incubation and quantitative analysis of Streptococcus Mutans. Morphological identification of the bacterial colonies was then confirmed using Matrix Assisted Laser Desorption/Ionization Time of Flight (MALDI-TOF) mass spectrometry.

Arms:
arm 1: An oral rinse given to pediatric patients in routine practice within the standard of care. arm 2: An oral rinse given to pediatric patients in routine practice within the standard of care. arm 3: A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained. arm 4: Water that has had the majority of its ions removed.

Interventions: intervention 1: Chlorhexidine gluconate (0.12%) intervention 2: Sodium Fluoride (0.05%) intervention 3: Paraffin wax chewing gum (sugar-free) intervention 4: Deionized water
Intervention descriptions: intervention 1: 30 second oral rinse of 10mL of solution intervention 2: 30 second oral rinse of 10mL of solution intervention 3: Approximately two minutes of chew time intervention 4: 30 second oral rinse of 10mL of solution

Protocol document: