Trial Outcomes & Findings for Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction (NCT NCT02598778)
NCT ID: NCT02598778
Last Updated: 2022-10-31
Results Overview
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).
TERMINATED
PHASE2
12 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)
2022-10-31
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
Deionized Water
Water that has had the majority of its ions removed.
Deionized water: 30 second oral rinse expectorate of 10mL of solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
4
|
2
|
|
Overall Study
COMPLETED
|
2
|
4
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not collected for Sex/Gender
Baseline characteristics by cohort
| Measure |
Chlorhexidine Gluconate (0.12%)
n=2 Participants
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
|
Sodium Fluoride (0.05%)
n=4 Participants
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
|
Paraffin Wax Chewing Gum (Sugar-free)
n=4 Participants
A food product serving as placebo.
Paraffin wax chewing gum (sugar-free): 2 minutes of chew time prior to salivary sample being obtained
|
Deionized Water
n=2 Participants
Water that has had the majority of its ions removed.
Deionized water: 30 second oral rinse expectorate of 10mL of solution
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
—
|
0 Participants
Data were not collected for Sex/Gender
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
—
|
0 Participants
Data were not collected for Sex/Gender
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
2 participants
n=2 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Chlorhexidine Gluconate (0.12%)
n=2 Samples
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
|
Sodium Fluoride (0.05%)
n=4 Samples
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
|
Paraffin Wax Chewing Gum (Sugar-free)
n=4 Samples
A food product serving as placebo.
Paraffin wax chewing gum (sugar-free): 2 minutes of chew time prior to salivary sample being obtained
|
Deionized Water
n=2 Samples
Water that has had the majority of its ions removed.
Deionized water: 30 second oral rinse expectorate of 10mL of solution
|
|---|---|---|---|---|
|
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
|
-75 Percentage change in S. mutans colonies
|
53.13 Percentage change in S. mutans colonies
|
-39.29 Percentage change in S. mutans colonies
|
|
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
|
-100 Percentage change in S. mutans colonies
|
88.89 Percentage change in S. mutans colonies
|
-46.15 Percentage change in S. mutans colonies
|
|
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
|
161.54 Percentage change in S. mutans colonies
|
—
|
|
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
|
176.26 Percentage change in S. mutans colonies
|
—
|
Adverse Events
Chlorhexidine Gluconate (0.12%)
Sodium Fluoride (0.05%)
Paraffin Wax Chewing Gum (Sugar-free)
Deionized Water
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place