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

October 3, 2022 updated by: Nuntiya Kakanantadilok, Montefiore Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Chlorhexidine gluconate (0.12%)
An oral rinse given to pediatric patients in routine practice within the standard of care.
Drug: Chlorhexidine gluconate (0.12%)
30 second oral rinse of 10mL of solution
Other Names:
  • Peridex
ACTIVE_COMPARATOR: Sodium Fluoride (0.05%)
An oral rinse given to pediatric patients in routine practice within the standard of care.
Drug: Sodium Fluoride (0.05%)
30 second oral rinse of 10mL of solution
Other Names:
  • ACT brand anticavity mouthrinse
PLACEBO_COMPARATOR: Paraffin wax chewing gum (sugar-free)
A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained.
Other: Paraffin wax chewing gum (sugar-free)
Approximately two minutes of chew time
PLACEBO_COMPARATOR: Deionized water
Water that has had the majority of its ions removed.
Other: Deionized water
30 second oral rinse of 10mL of solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2015

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (ESTIMATE)

November 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-5583

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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