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.
Brief Title
Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Dental Caries
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Streptococcus Mutans
Saliva
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
12 Years
Minimum Age
6 Years
NCT Id
NCT02598778
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5583
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparing Chlorhexidine Gluconate Rinse, Sodium Fluoride Rinse, Water Rinse, and Chewing Gum in Regard to Streptococcus Mutans Reduction
Primary Outcomes
Outcome 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).
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).
Outcome Measure
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)
Outcome 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)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
12
Minimum Age Number (converted to Years and rounded down)
6
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nuntiya Kakanantadilok
Investigator Email
nkakanan@montefiore.org
Investigator Phone
Categories Mesh Debug
Digestive System --- STOMATOGNATHIC DISEASES
MeSH Terms
DENTAL CARIES
TOOTH DEMINERALIZATION
TOOTH DISEASES
STOMATOGNATHIC DISEASES
CHLORHEXIDINE GLUCONATE
SODIUM FLUORIDE
FLUORIDES
HYDROFLUORIC ACID
FLUORINE COMPOUNDS
INORGANIC CHEMICALS
SODIUM COMPOUNDS
CARIOSTATIC AGENTS
BIOMEDICAL AND DENTAL MATERIALS
MANUFACTURED MATERIALS
TECHNOLOGY, INDUSTRY, AND AGRICULTURE