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

Primary Purpose

Dental Caries

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate (0.12%)
Sodium Fluoride (0.05%)
Paraffin wax chewing gum (sugar-free)
Deionized water
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dental Caries focused on measuring Streptococcus Mutans, Saliva

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Chlorhexidine gluconate (0.12%)

Sodium Fluoride (0.05%)

Paraffin wax chewing gum (sugar-free)

Deionized water

Arm Description

An oral rinse given to pediatric patients in routine practice within the standard of care.

An oral rinse given to pediatric patients in routine practice within the standard of care.

A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained.

Water that has had the majority of its ions removed.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 4, 2015
Last Updated
October 3, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02598778
Brief Title
Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction
Official Title
Comparing Chlorhexidine Gluconate Rinse, Sodium Fluoride Rinse, Water Rinse, and Chewing Gum in Regard to Streptococcus Mutans Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Study discontinued early due to time constraints and lack of selectivity in agar used in the identification of the target (Streptococcus mutans). Only 12 participants out of a planned 40 were enrolled.
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
April 1, 2016 (Actual)
Study Completion Date
April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Streptococcus Mutans, Saliva

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine gluconate (0.12%)
Arm Type
Active Comparator
Arm Description
An oral rinse given to pediatric patients in routine practice within the standard of care.
Arm Title
Sodium Fluoride (0.05%)
Arm Type
Active Comparator
Arm Description
An oral rinse given to pediatric patients in routine practice within the standard of care.
Arm Title
Paraffin wax chewing gum (sugar-free)
Arm Type
Placebo Comparator
Arm Description
A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained.
Arm Title
Deionized water
Arm Type
Placebo Comparator
Arm Description
Water that has had the majority of its ions removed.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate (0.12%)
Other Intervention Name(s)
Peridex
Intervention Description
30 second oral rinse of 10mL of solution
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride (0.05%)
Other Intervention Name(s)
ACT brand anticavity mouthrinse
Intervention Description
30 second oral rinse of 10mL of solution
Intervention Type
Other
Intervention Name(s)
Paraffin wax chewing gum (sugar-free)
Intervention Description
Approximately two minutes of chew time
Intervention Type
Other
Intervention Name(s)
Deionized water
Intervention Description
30 second oral rinse of 10mL of solution
Primary Outcome Measure Information:
Title
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)
Description
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).
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuntiya Kakanantadilok, DMD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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

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