Dental Caries
Conditions
Keywords
Streptococcus Mutans, Saliva
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.
Interventions
DRUGChlorhexidine gluconate (0.12%)
30 second oral rinse of 10mL of solution
DRUGSodium Fluoride (0.05%)
30 second oral rinse of 10mL of solution
OTHERParaffin wax chewing gum (sugar-free)
Approximately two minutes of chew time
OTHERDeionized water
30 second oral rinse of 10mL of solution
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Gluconate (0.12%) An oral rinse given to pediatric patients in routine practice within the standard of care.
Chlorhexidine gluconate (0.12%): 30 second oral rinse expectorate of 10mL of solution | 2 |
| Sodium Fluoride (0.05%) An oral rinse given to pediatric patients in routine practice within the standard of care.
Sodium Fluoride (0.05%): 30 second oral rinse expectorate of 10mL of solution | 4 |
| Paraffin Wax Chewing Gum (Sugar-free) A food product serving as placebo.
Paraffin wax chewing gum (sugar-free): 2 minutes of chew time prior to salivary sample being obtained | 4 |
| Deionized Water Water that has had the majority of its ions removed.
Deionized water: 30 second oral rinse expectorate of 10mL of solution | 2 |
| Total | 12 |
Baseline characteristics
| Characteristic | Chlorhexidine Gluconate (0.12%) | Total | Deionized Water | Paraffin Wax Chewing Gum (Sugar-free) | Sodium Fluoride (0.05%) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 12 Participants | 2 Participants | 4 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 2 participants | 12 participants | 2 participants | 4 participants | 4 participants |
| Sex: Female, Male Female | — | 0 Participants | — | — | — |
| Sex: Female, Male Male | — | 0 Participants | — | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 4 | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 | 0 / 4 | 0 / 2 |
Outcome results
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).
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)
Population: 1 pre (baseline) and post sample was collected and analyzed from each participant. As such, there were 2 pre and 2 post samples for the Chlorhexidine gluconate Arm/Group, 4 pre and 4 post samples for the Sodium Fluoride Arm/Group, 4 pre and 4 post samples for the Paraffin wax chewing gum Arm/Group, and 2 pre and 2 post samples for the Deionized water Arm/Group. Values in Outcome Measure Data table reflects percentage change (increase/decrease) in S. mutans colonies from pre (baseline) to post.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chlorhexidine Gluconate (0.12%) | 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) | First Participant | -100 Percentage change in S. mutans colonies |
| Chlorhexidine Gluconate (0.12%) | 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) | Second Participant | -100 Percentage change in S. mutans colonies |
| Sodium Fluoride (0.05%) | 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) | First Participant | -75 Percentage change in S. mutans colonies |
| Sodium Fluoride (0.05%) | 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) | Fourth Participant | -100 Percentage change in S. mutans colonies |
| Sodium Fluoride (0.05%) | 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) | Third Participant | -100 Percentage change in S. mutans colonies |
| Sodium Fluoride (0.05%) | 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) | Second Participant | -100 Percentage change in S. mutans colonies |
| Paraffin Wax Chewing Gum (Sugar-free) | 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) | Fourth Participant | 176.26 Percentage change in S. mutans colonies |
| Paraffin Wax Chewing Gum (Sugar-free) | 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) | First Participant | 53.13 Percentage change in S. mutans colonies |
| Paraffin Wax Chewing Gum (Sugar-free) | 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) | Second Participant | 88.89 Percentage change in S. mutans colonies |
| Paraffin Wax Chewing Gum (Sugar-free) | 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) | Third Participant | 161.54 Percentage change in S. mutans colonies |
| Deionized Water | 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) | Second Participant | -46.15 Percentage change in S. mutans colonies |
| Deionized Water | 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) | First Participant | -39.29 Percentage change in S. mutans colonies |