NCT02598778

Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction

Comparing Chlorhexidine Gluconate Rinse, Sodium Fluoride Rinse, Water Rinse, and Chewing Gum in Regard to Streptococcus Mutans Reduction

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Chlorhexidine gluconate (0.12%)	30 second oral rinse of 10mL of solution
DRUG	Sodium Fluoride (0.05%)	30 second oral rinse of 10mL of solution
OTHER	Paraffin wax chewing gum (sugar-free)	Approximately two minutes of chew time
OTHER	Deionized water	30 second oral rinse of 10mL of solution

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-11-06
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study