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

Montefiore Medicine Academic Health System

Status and phase: Terminated; Phase 2

Conditions: Dental Caries

Treatments: Drug: Sodium Fluoride (0.05%); Drug: Chlorhexidine gluconate (0.12%); Other: Deionized water; Other: Paraffin wax chewing gum (sugar-free)

Study type: Interventional

Funder types: Other

Identifiers

NCT02598778

2015-5583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups, including a placebo group

Chlorhexidine gluconate (0.12%)

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine gluconate (0.12%)

Sodium Fluoride (0.05%)

Active Comparator group

Description:

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

Treatment:

Drug: Sodium Fluoride (0.05%)

Paraffin wax chewing gum (sugar-free)

Placebo Comparator group

Description:

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

Treatment:

Other: Paraffin wax chewing gum (sugar-free)

Deionized water

Placebo Comparator group

Description:

Water that has had the majority of its ions removed.

Treatment:

Other: Deionized water