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caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited. Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before and after the treatment for laboratory analyses.
21 caries-free (CF) individuals with no clinical evidence of caries experience [decayed, missing and filled teeth (DMFT) = 0] and 21 caries-active (CA) individuals (DMFT ≥ 6) will be recruited in the clinical trial. The exclusion criteria are: smoker or former smoker, presence of any systemic disease that could alter the production or composition of saliva, treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3 months, and presence of dental prostheses or orthodontic devices. Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Volunteers are asked to refrain from brushing and flossing their teeth, eating, and drinking anything other than water for 12 h prior to sample collection visits at the end of both phases. Supra- and subgingival plaque (15 subjects in each group), saliva (21 subjects in each group), and in situ plaque samples (3 subjects in each group) will be collected before and after the treatment. Scraped plaque and saliva samples will be immediately transferred to and dispersed in sterile micro-centrifuge tubes containing 1×phosphate-buffered saline (PBS), and stored at -80 °C until needed for analysis. The in situ plaque samples will be transferred into 4% paraformaldehyde, kept under 4 °C for 16 h, and then stored in 50% (v/v) ethanol at -20 °C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caries-free subjects | Active Comparator | Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,. |
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| Caries-active subjects | Experimental | Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate® Sensitive Pro-Relief® toothpaste | Other | Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing | 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. | baseline , 2 week |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays | 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. | baseline ,2 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Xu, D.D.S | West China Hospital of Stomatology, Sichuan University | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Caries-active Subjects |
| Units | Counts |
|---|---|
| Participants |
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| 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 | The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing | 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. | Posted | Mean | Standard Deviation | percentage of bacteria | baseline , 2 week |
|
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xin Xu | Sichuan University | 86-28-85503494 | xin.xu@scu.edu.cn |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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.
|
|
| Secondary | The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays | 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. | Among the 21 participants in each group，we only measured the enzyme activity from randomly choosed 15 participants from each group. | Posted | Mean | Standard Deviation | enzyme activity (μmol/min/g) | baseline ,2 week |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| baseline: ADS activity in saliva plaque |
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| baseline: urease activity in supragingival plaque |
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| baseline: urease activity in subgingival plaque |
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| baseline: urease activity in saliva |
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| baseline: LDH activity in supragingival plaque |
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| baseline: LDH activity in subgingival plaque |
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| baseline: LDH activity in saliva |
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| 2 week: ADS activity in supragingival plaque |
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| 2 week: ADS activity in subgingival plaque |
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| 2 week: ADS activity in saliva |
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| 2 week: urease activity in supragingival plaque |
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| 2 week: urease activity in subgingival plaque |
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| 2 week: urease activity in saliva |
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| 2 week: LDH activity in supragingival plaque |
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| 2 week: LDH activity in subgingival plaque |
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| 2 week: LDH activity in saliva |
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