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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2016-04-01

Brief Summary

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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.

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Detailed Description

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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

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chlorhexidine gluconate (0.12%)

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate (0.12%)

Intervention Type DRUG

30 second oral rinse of 10mL of solution

Sodium Fluoride (0.05%)

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

Group Type ACTIVE_COMPARATOR

Sodium Fluoride (0.05%)

Intervention Type DRUG

30 second oral rinse of 10mL of solution

Paraffin wax chewing gum (sugar-free)

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

Group Type PLACEBO_COMPARATOR

Paraffin wax chewing gum (sugar-free)

Intervention Type OTHER

Approximately two minutes of chew time

Deionized water

Water that has had the majority of its ions removed.

Group Type PLACEBO_COMPARATOR

Deionized water

Intervention Type OTHER

30 second oral rinse of 10mL of solution

Interventions

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Chlorhexidine gluconate (0.12%)

30 second oral rinse of 10mL of solution

Intervention Type DRUG

Sodium Fluoride (0.05%)

30 second oral rinse of 10mL of solution

Intervention Type DRUG

Paraffin wax chewing gum (sugar-free)

Approximately two minutes of chew time

Intervention Type OTHER

Deionized water

30 second oral rinse of 10mL of solution

Intervention Type OTHER

Other Intervention Names

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Peridex ACT brand anticavity mouthrinse

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes