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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02598778
• Other study ID #: 2015-5583
• Status: Terminated
• Phase: Phase 2
• Start date: November 1, 2015
• Est. completion date: April 1, 2016

Study information

• Verified date: October 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 1, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients presenting to the dental clinic for routine dental treatment (including recall exams, new patient exams, and operative appointments) who are American Society of Anesthesia (ASA) class I or II
• Cooperative patients classified as 3 or 4 according to the Frankl Behavioral Rating Scale,
• No known allergies or sensitivities to products or ingredients being tested
• Had untreated cavities
• Nothing to eat/drink for 1 hour prior to dental appointment

Exclusion Criteria:

• Patients who are ASA class III, IV, V or VI
• Known allergies or sensitivities to any of the mouth rinses or any of the ingredients in the mouth rinses to be tested
• Non-English speaking parent/participant
• Patient presenting to the clinic as a walk in or emergency appointment
• Patient experiencing any pain or sensitivity
• Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to the Frankl Behavioral Rating Scale

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Chlorhexidine gluconate (0.12%)
30 second oral rinse of 10mL of solution
• 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
• Deionized water
30 second oral rinse of 10mL of solution

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Salivary Streptococcus Mutans Levels After 30 Second Oral Rinse Time (Chlorhexidine Gluconate, Sodium Fluoride, or Deionized Water) or 2 Minute Chew Time (Paraffin Wax Chewing Gum)	Oral salivary sample obtained and plated on MSB (mitis salivarius-bacitracin) agar petri dish to determine Streptococcus mutans (S. mutans) levels.; Values in each row in the Outcome Measure Data Table represent percentage change (increase denoted by positive number, decrease denoted by negative number) in S. mutans colonies from baseline (pre rinse/chew) sample for a single participant within that particular Arm/Group. Row titles have been arbitrarily identified as 'First Participant', 'Second Participant', 'Third Participant' and 'Fourth Participant.' No values are shown for 'Third Participant' and 'Fourth Participant' for the Chlorhexidine gluconate (0.12%) and Deionized water Arm/Group since only 2 participants were enrolled within each group. One result is obtained from each pre and post sample combination (percentage change).	Sample obtained at baseline (pre rinse/chew) and immediately after treatment (post rinse/chew). Timed for 30 seconds (oral rinses) or 2 minutes (chewing gum)