Trial Outcomes & Findings for Ecological Effect of Arginine Dentifrice on Oral Microbiota (NCT NCT02988349)
NCT ID: NCT02988349
Last Updated: 2018-11-13
Results Overview
Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
baseline , 2 week
Results posted on
2018-11-13
Participant Flow
The first recruitment took place on Oct. 2013, in the Department of Operative Dentistry and Endodontics, West China Hospital of Stomatology. 15 CF and 15 CA individuals were recruited by the end of Nov. 2013. The second recruitment took place on May in the same location. 2014. 6 CF and 6 CA individuals were recruited by the end of Jun. 2014.
Participant milestones
| Measure |
Caries-free Subjects
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
Caries-active Subjects
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ecological Effect of Arginine Dentifrice on Oral Microbiota
Baseline characteristics by cohort
| Measure |
Caries-free Subjects
n=21 Participants
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
Caries-active Subjects
n=21 Participants
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23 years
n=5 Participants
|
23 years
n=7 Participants
|
23 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline , 2 weekSaliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.
Outcome measures
| Measure |
Caries-free Subjects
n=21 Participants
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
Caries-active Subjects
n=21 Participants
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
|---|---|---|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Baseline: sm in supragingival plaque
|
0.00756 percentage of bacteria
Standard Deviation 0.00726
|
0.14636 percentage of bacteria
Standard Deviation 0.23221
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Baseline: sm in subgingival plaque
|
0.00629 percentage of bacteria
Standard Deviation 0.00835
|
0.11956 percentage of bacteria
Standard Deviation 0.20686
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Baseline: sm in saliva
|
0.00608 percentage of bacteria
Standard Deviation 0.00575
|
0.01314 percentage of bacteria
Standard Deviation 0.01272
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Baseline: ss in supragingival plaque
|
1.007766667 percentage of bacteria
Standard Deviation 1.168793223
|
0.521506667 percentage of bacteria
Standard Deviation 0.511640082
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Baseline: ss in subgingival plaque
|
2.064646667 percentage of bacteria
Standard Deviation 2.595662011
|
1.539913333 percentage of bacteria
Standard Deviation 1.369851357
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Baseline: ss in saliva
|
0.812706667 percentage of bacteria
Standard Deviation 1.040344461
|
0.18324 percentage of bacteria
Standard Deviation 0.199811864
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
2 week: sm in supragingival plaque
|
0.003406667 percentage of bacteria
Standard Deviation 0.003320384
|
0.009526667 percentage of bacteria
Standard Deviation 0.011458775
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
2 week: sm in subgingival plaque
|
0.0033 percentage of bacteria
Standard Deviation 0.006143173
|
0.00284 percentage of bacteria
Standard Deviation 0.005101792
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
2 week: sm in saliva
|
0.002493333 percentage of bacteria
Standard Deviation 0.004110347
|
0.003006667 percentage of bacteria
Standard Deviation 0.002304488
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
2 week: ss in supragingival plaque
|
1.655106667 percentage of bacteria
Standard Deviation 1.274066247
|
3.21486 percentage of bacteria
Standard Deviation 3.436273455
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
2 week: ss in subgingival plaque
|
4.588546667 percentage of bacteria
Standard Deviation 4.92217214
|
3.232233333 percentage of bacteria
Standard Deviation 3.336652867
|
|
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
2 week: ss in saliva
|
1.3109 percentage of bacteria
Standard Deviation 0.885269549
|
2.040286667 percentage of bacteria
Standard Deviation 3.369773515
|
SECONDARY outcome
Timeframe: baseline ,2 weekPopulation: Among the 21 participants in each group，we only measured the enzyme activity from randomly choosed 15 participants from each group.
Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.
Outcome measures
| Measure |
Caries-free Subjects
n=15 Participants
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
Caries-active Subjects
n=15 Participants
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
|
|---|---|---|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: ADS activity in supragingival plaque
|
0.8945 enzyme activity (μmol/min/g)
Standard Deviation 0.13310
|
0.3653 enzyme activity (μmol/min/g)
Standard Deviation 0.06108
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: ADS activity in subgingival plaque
|
0.63150 enzyme activity (μmol/min/g)
Standard Deviation 0.08604
|
0.29110 enzyme activity (μmol/min/g)
Standard Deviation 0.04347
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: ADS activity in saliva plaque
|
0.75870 enzyme activity (μmol/min/g)
Standard Deviation 0.09211
|
0.23470 enzyme activity (μmol/min/g)
Standard Deviation 0.03328
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: urease activity in supragingival plaque
|
0.6795 enzyme activity (μmol/min/g)
Standard Deviation 0.11518
|
0.3207 enzyme activity (μmol/min/g)
Standard Deviation 0.06317
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: urease activity in subgingival plaque
|
0.71840 enzyme activity (μmol/min/g)
Standard Deviation 0.08770
|
0.34630 enzyme activity (μmol/min/g)
Standard Deviation 0.04611
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: urease activity in saliva
|
0.72900 enzyme activity (μmol/min/g)
Standard Deviation 0.66210
|
0.17920 enzyme activity (μmol/min/g)
Standard Deviation 0.03047
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: LDH activity in supragingival plaque
|
8.859050 enzyme activity (μmol/min/g)
Standard Deviation 0.6648584
|
20.965090 enzyme activity (μmol/min/g)
Standard Deviation 1.549900
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: LDH activity in subgingival plaque
|
7.267220 enzyme activity (μmol/min/g)
Standard Deviation 0.2555969
|
17.576110 enzyme activity (μmol/min/g)
Standard Deviation 0.887500
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
baseline: LDH activity in saliva
|
7.508787 enzyme activity (μmol/min/g)
Standard Deviation 0.8707994
|
16.053870 enzyme activity (μmol/min/g)
Standard Deviation 2.361490
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: ADS activity in supragingival plaque
|
1.0771 enzyme activity (μmol/min/g)
Standard Deviation 0.23754
|
0.8418 enzyme activity (μmol/min/g)
Standard Deviation 0.13711
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: ADS activity in subgingival plaque
|
0.74650 enzyme activity (μmol/min/g)
Standard Deviation 0.10275
|
0.73600 enzyme activity (μmol/min/g)
Standard Deviation 0.07218
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: ADS activity in saliva
|
0.77410 enzyme activity (μmol/min/g)
Standard Deviation 0.11136
|
0.34850 enzyme activity (μmol/min/g)
Standard Deviation 0.04391
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: urease activity in supragingival plaque
|
0.5871 enzyme activity (μmol/min/g)
Standard Deviation 0.07970
|
0.6508 enzyme activity (μmol/min/g)
Standard Deviation 0.10083
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: urease activity in subgingival plaque
|
0.73330 enzyme activity (μmol/min/g)
Standard Deviation 0.06165
|
0.69680 enzyme activity (μmol/min/g)
Standard Deviation 0.08427
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: urease activity in saliva
|
0.73240 enzyme activity (μmol/min/g)
Standard Deviation 0.05464
|
0.25260 enzyme activity (μmol/min/g)
Standard Deviation 0.04560
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: LDH activity in supragingival plaque
|
11.347060 enzyme activity (μmol/min/g)
Standard Deviation 0.9240766
|
14.096910 enzyme activity (μmol/min/g)
Standard Deviation 0.3565668
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: LDH activity in subgingival plaque
|
8.664124 enzyme activity (μmol/min/g)
Standard Deviation 0.8184378
|
11.649030 enzyme activity (μmol/min/g)
Standard Deviation 1.135210
|
|
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
2 week: LDH activity in saliva
|
9.496731 enzyme activity (μmol/min/g)
Standard Deviation 0.1797688
|
15.268450 enzyme activity (μmol/min/g)
Standard Deviation 0.3687766
|
Adverse Events
Caries-free Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caries-active Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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