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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine gluconate (0.12%) | Active Comparator | An oral rinse given to pediatric patients in routine practice within the standard of care. |
|
| Sodium Fluoride (0.05%) | Active Comparator | An oral rinse given to pediatric patients in routine practice within the standard of care. |
|
| Paraffin wax chewing gum (sugar-free) | Placebo Comparator | A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained. |
|
| Deionized water | Placebo Comparator | Water that has had the majority of its ions removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate (0.12%) | Drug | 30 second oral rinse of 10mL of solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuntiya Kakanantadilok, DMD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Sodium Fluoride (0.05%) | An oral rinse given to pediatric patients in routine practice within the standard of care. Sodium Fluoride oral rinse (0.05%): 30 second oral rinse expectorate of 10mL of solution |
| FG002 | 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 |
| FG003 | Deionized Water | Water that has had the majority of its ions removed. Deionized water: 30 second oral rinse expectorate of 10mL of solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sodium Fluoride (0.05%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | Percentage change in S. mutans colonies |
From the initiation of oral rinse/chew to the time of expectoration/spit (30 seconds - 2 minutes)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine Gluconate (0.12%) | An oral rinse given to pediatric patients in routine practice within the standard of care. Chlorhexidine gluconate (.12%): 30 second oral rinse expectorate of 10mL of solution |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kakanantadilok, Nuntiya | MMC - Dentistry | (888) 700-6623 | nkakanan@montefiore.org |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium Fluoride (0.05%) | Drug | 30 second oral rinse of 10mL of solution |
|
|
| Paraffin wax chewing gum (sugar-free) | Other | Approximately two minutes of chew time |
|
| Deionized water | Other | 30 second oral rinse of 10mL of solution |
|
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 |
| BG002 | 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 |
| BG003 | Deionized Water | Water that has had the majority of its ions removed. Deionized water: 30 second oral rinse expectorate of 10mL of solution |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Data were not collected for Sex/Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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) |
| Samples |
| Samples |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Sodium Fluoride (0.05%) | An oral rinse given to pediatric patients in routine practice within the standard of care. Sodium Fluoride (.05%): 30 second oral rinse expectorate of 10mL of solution | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Deionized Water | Water that has had the majority of its ions removed. Deionized water: 30 second oral rinse expectorate of 10mL of solution | 0 | 2 | 0 | 2 | 0 | 2 |
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| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Between 18 and 65 years |
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| >=65 years |
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