An interventional study of Colgate® Sensitive Pro-Relief® toothpaste in Dental Caries, Oral Bacterial Infection and Microbiota, sponsored by Sichuan University. Completed. Per ClinicalTrials.gov, last updated 2018-11-13.
Sponsored by Sichuan University · Not applicable, Interventional, and Treatment
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.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 42 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Other: Colgate® Sensitive Pro-Relief® toothpaste
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Other: 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
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.
Time frame: baseline , 2 week
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.
Time frame: baseline ,2 week
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.
| Milestone | Caries-free Subjects | Caries-active Subjects |
|---|---|---|
| Started | 21 | 21 |
| Completed | 21 | 21 |
| Not completed | 0 | 0 |
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.
| percentage of bacteria | Caries-free Subjects | Caries-active Subjects |
|---|---|---|
| Baseline: sm in supragingival plaque | 0.00756 ± 0.00726 | 0.14636 ± 0.23221 |
| Baseline: sm in subgingival plaque | 0.00629 ± 0.00835 | 0.11956 ± 0.20686 |
| Baseline: sm in saliva | 0.00608 ± 0.00575 | 0.01314 ± 0.01272 |
| Baseline: ss in supragingival plaque | 1.007766667 ± 1.168793223 | 0.521506667 ± 0.511640082 |
| Baseline: ss in subgingival plaque | 2.064646667 ± 2.595662011 | 1.539913333 ± 1.369851357 |
| Baseline: ss in saliva | 0.812706667 ± 1.040344461 | 0.18324 ± 0.199811864 |
| 2 week: sm in supragingival plaque | 0.003406667 ± 0.003320384 | 0.009526667 ± 0.011458775 |
| 2 week: sm in subgingival plaque | 0.0033 ± 0.006143173 | 0.00284 ± 0.005101792 |
| 2 week: sm in saliva | 0.002493333 ± 0.004110347 | 0.003006667 ± 0.002304488 |
| 2 week: ss in supragingival plaque | 1.655106667 ± 1.274066247 | 3.21486 ± 3.436273455 |
| 2 week: ss in subgingival plaque | 4.588546667 ± 4.92217214 | 3.232233333 ± 3.336652867 |
| 2 week: ss in saliva | 1.3109 ± 0.885269549 | 2.040286667 ± 3.369773515 |
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.
| enzyme activity (μmol/min/g) | Caries-free Subjects | Caries-active Subjects |
|---|---|---|
| baseline: ADS activity in supragingival plaque | 0.8945 ± 0.13310 | 0.3653 ± 0.06108 |
| baseline: ADS activity in subgingival plaque | 0.63150 ± 0.08604 | 0.29110 ± 0.04347 |
| baseline: ADS activity in saliva plaque | 0.75870 ± 0.09211 | 0.23470 ± 0.03328 |
| baseline: urease activity in supragingival plaque | 0.6795 ± 0.11518 | 0.3207 ± 0.06317 |
| baseline: urease activity in subgingival plaque | 0.71840 ± 0.08770 | 0.34630 ± 0.04611 |
| baseline: urease activity in saliva | 0.72900 ± 0.66210 | 0.17920 ± 0.03047 |
| baseline: LDH activity in supragingival plaque | 8.859050 ± 0.6648584 | 20.965090 ± 1.549900 |
| baseline: LDH activity in subgingival plaque | 7.267220 ± 0.2555969 | 17.576110 ± 0.887500 |
| baseline: LDH activity in saliva | 7.508787 ± 0.8707994 | 16.053870 ± 2.361490 |
| 2 week: ADS activity in supragingival plaque | 1.0771 ± 0.23754 | 0.8418 ± 0.13711 |
| 2 week: ADS activity in subgingival plaque | 0.74650 ± 0.10275 | 0.73600 ± 0.07218 |
| 2 week: ADS activity in saliva | 0.77410 ± 0.11136 | 0.34850 ± 0.04391 |
| 2 week: urease activity in supragingival plaque | 0.5871 ± 0.07970 | 0.6508 ± 0.10083 |
| 2 week: urease activity in subgingival plaque | 0.73330 ± 0.06165 | 0.69680 ± 0.08427 |
| 2 week: urease activity in saliva | 0.73240 ± 0.05464 | 0.25260 ± 0.04560 |
| 2 week: LDH activity in supragingival plaque | 11.347060 ± 0.9240766 | 14.096910 ± 0.3565668 |
| 2 week: LDH activity in subgingival plaque | 8.664124 ± 0.8184378 | 11.649030 ± 1.135210 |
| 2 week: LDH activity in saliva | 9.496731 ± 0.1797688 | 15.268450 ± 0.3687766 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caries-free Subjects | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Caries-active Subjects | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Caries-free Subjects | Caries-active Subjects | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Caries-free Subjects | Caries-active Subjects | Total |
|---|---|---|---|
| Median | 23 (19 to 31) | 23 (19 to 28) | 23 (19 to 31) |
| Sex: Female, Male(Participants) | Caries-free Subjects | Caries-active Subjects | Total |
|---|---|---|---|
| Female | 11 | 17 | 28 |
| Male | 10 | 4 | 14 |
| Region of Enrollment(Participants) | Caries-free Subjects | Caries-active Subjects | Total |
|---|---|---|---|
| China | 21 | 21 | 42 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sichuan University