Trial Outcomes & Findings for Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk (NCT NCT04399161)
NCT ID: NCT04399161
Last Updated: 2020-07-22
Results Overview
Change in Streptococcus mutans levels in dental plaque after using mouth rinses for 14 days to determine their antimicrobial efficacy.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Assessment of change in Streptococcus mutans levels 14 days after intervention
Results posted on
2020-07-22
Participant Flow
Children: Participants were chosen from a government residential school located in Mysuru. Elderly: Participants were chosen from an old age home in Mysuru.
Streptococcus mutans count determined in 72 participants Children: 36 of 45 fulfilled eligibility criteria. 6 participants were excluded before allocation (reason: left school). Elderly: 36 of 70 fulfilled eligibility criteria. 6 participants were excluded before allocation (reason: died, didn't co-operate).
Participant milestones
| Measure |
Group A (Chlorhexidine Mouthrinse)
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
|
Group B (Xylitol Mouth Rinse)
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
|
Group C (Probiotic Mouth Rinse)
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group A (Chlorhexidine Mouthrinse)
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
|
Group B (Xylitol Mouth Rinse)
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
|
Group C (Probiotic Mouth Rinse)
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed before intervention and by the end of 14 days after intervention.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A (Chlorhexidine Mouthrinse)
n=20 Participants
A commercially available Chlorhexidine mouth rinse (Hexidine- 0.2 percentage Chlorhexidine gluconate) containing 0.2 percentage chlorhexidine gluconate per 10 ml was used. 7.5 ml of the concentrate diluted with equal amounts of water to make 15 ml was used for rinsing.
Children (5-12 years) at high risk for dental caries: 20
Elderly (above 60 years) at high risk for dental caries: 20
|
Group B (Xylitol Mouth Rinse)
n=20 Participants
Xylitol mouth rinse at 10 percentage concentration was used. The mouth rinse was prepared by dissolving 1.5 gm of xylitol powder in 15 ml of water.
Children (5-12 years) at high risk for dental caries: 20
Elderly (above 60 years) at high risk for dental caries: 20
|
Group C (Probiotic Mouth Rinse)
n=20 Participants
Probiotic mouth rinse was prepared by using a commercially available probiotic product (Sporolac Plus powder- 1gm sachet containing not less than 1.5 billion cells of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Bacillus coagulans, Saccharomyces boulardii). Each sachet was dissolved in 15 ml of water in a measuring cup and used as a mouth rinse.
Children (5-12 years) at high risk for dental caries: 20
Elderly (above 60 years) at high risk for dental caries: 20
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Children (5-12 years)
|
10 participants
n=20 Participants
|
10 participants
n=20 Participants
|
10 participants
n=20 Participants
|
30 participants
n=60 Participants
|
|
Age, Customized
Elderly (above 60 years)
|
10 participants
n=20 Participants
|
10 participants
n=20 Participants
|
10 participants
n=20 Participants
|
30 participants
n=60 Participants
|
|
Sex/Gender, Customized
Children (males)
|
4 participants
n=20 Participants
|
7 participants
n=20 Participants
|
7 participants
n=20 Participants
|
18 participants
n=60 Participants
|
|
Sex/Gender, Customized
Children (females)
|
6 participants
n=20 Participants
|
3 participants
n=20 Participants
|
3 participants
n=20 Participants
|
12 participants
n=60 Participants
|
|
Sex/Gender, Customized
Elderly (males)
|
2 participants
n=20 Participants
|
3 participants
n=20 Participants
|
2 participants
n=20 Participants
|
7 participants
n=60 Participants
|
|
Sex/Gender, Customized
Elderly (females)
|
8 participants
n=20 Participants
|
7 participants
n=20 Participants
|
8 participants
n=20 Participants
|
23 participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Streptococcus mutans count
Children
|
6.43 log10CFU/g
STANDARD_DEVIATION 1.28 • n=10 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
6.60 log10CFU/g
STANDARD_DEVIATION 0.95 • n=10 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
6.88 log10CFU/g
STANDARD_DEVIATION 0.76 • n=10 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
6.65 log10CFU/g
STANDARD_DEVIATION 0.97 • n=30 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
|
Streptococcus mutans count
Elderly
|
7.13 log10CFU/g
STANDARD_DEVIATION 1.15 • n=10 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
6.42 log10CFU/g
STANDARD_DEVIATION 1.10 • n=10 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
7.16 log10CFU/g
STANDARD_DEVIATION 0.80 • n=10 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
6.89 log10CFU/g
STANDARD_DEVIATION 1.04 • n=30 Participants • Streptococcus mutans count was assessed for 72 participants. 12 were excluded (left the study). The remaining 60 were randomly assigned to the 3 groups. Streptococcus mutans count of the participants assigned to the groups (ie: 60) was used for analysis
|
PRIMARY outcome
Timeframe: Assessment of change in Streptococcus mutans levels 14 days after interventionPopulation: Group A (Children): 9 out of 10 analyzed. 1 excluded. Group A (Elderly): 9 out of 10 analyzed. 1 excluded. Group B (Children): 9 out of 10 analyzed. 1 excluded. Group B (Elderly): 9 out of 10 were analyzed. 1 excluded. Group C (Children): All 10 were analyzed. Group C (Elderly): 8 out of 10 were analyzed. 2 excluded.
Change in Streptococcus mutans levels in dental plaque after using mouth rinses for 14 days to determine their antimicrobial efficacy.
Outcome measures
| Measure |
Group A (Chlorhexidine Mouthrinse)
n=18 Participants
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
|
Group B (Xylitol Mouth Rinse)
n=18 Participants
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
|
Group C (Probiotic Mouth Rinse)
n=18 Participants
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
|
|---|---|---|---|
|
Change in Streptococcus Mutans Levels in Dental Plaque
Children (5-12 years)
|
3.11 log10CFU/g
Standard Deviation 2.32
|
0.93 log10CFU/g
Standard Deviation 0.86
|
1.91 log10CFU/g
Standard Deviation 1.67
|
|
Change in Streptococcus Mutans Levels in Dental Plaque
Elderly (above 60 years)
|
2.23 log10CFU/g
Standard Deviation 1.08
|
1.39 log10CFU/g
Standard Deviation 0.81
|
1.61 log10CFU/g
Standard Deviation 0.92
|
Adverse Events
Group A (Chlorhexidine Mouthrinse)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group B (Xylitol Mouth Rinse)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C (Probiotic Mouth Rinse)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A (Chlorhexidine Mouthrinse)
n=20 participants at risk
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
|
Group B (Xylitol Mouth Rinse)
n=20 participants at risk
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
|
Group C (Probiotic Mouth Rinse)
n=20 participants at risk
Participants were asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse for 14 days. Streptococcus mutans count was assessed by the end of 14 days after intervention.
|
|---|---|---|---|
|
Gastrointestinal disorders
irritation of oral mucosa (burning sensation in the mouth and tongue)
|
10.0%
2/20 • 14 days
The intervention was carried out for a period of 14 days. A record log was maintained to document regular usage of the mouth rinse and also to record other (not so serious) adverse events like burning sensation in the mouth as a result of using the mouth rinses.
|
0.00%
0/20 • 14 days
The intervention was carried out for a period of 14 days. A record log was maintained to document regular usage of the mouth rinse and also to record other (not so serious) adverse events like burning sensation in the mouth as a result of using the mouth rinses.
|
0.00%
0/20 • 14 days
The intervention was carried out for a period of 14 days. A record log was maintained to document regular usage of the mouth rinse and also to record other (not so serious) adverse events like burning sensation in the mouth as a result of using the mouth rinses.
|
Additional Information
Dr. Krupa NC
JSS Dental College & Hospital, JSS Academy of Higher Education & Research
Phone: 8105064056
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place