Ecological Effect of Arginine Dentifrice on Oral Microbiota
Primary Purpose
Dental Caries, Oral Bacterial Infection, Microbiota
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colgate® Sensitive Pro-Relief® toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- caries-free individuals with no clinical evidence of caries experience [decayed, missing and filled teeth (DMFT) = 0] and caries-active individuals (DMFT ≥ 6) were recruited
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Caries-free subjects
Caries-active subjects
Arm Description
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02988349
Brief Title
Ecological Effect of Arginine Dentifrice on Oral Microbiota
Official Title
Ecological Effect of 8% Arginine Dentifrice on Oral Microbiota of Caries-Free and Caries-active Populations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Oral Bacterial Infection, Microbiota
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caries-free subjects
Arm Type
Active Comparator
Arm Description
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Arm Title
Caries-active subjects
Arm Type
Experimental
Arm Description
Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
Intervention Type
Other
Intervention Name(s)
Colgate® Sensitive Pro-Relief® toothpaste
Intervention Description
Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
Primary Outcome Measure Information:
Title
The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
Description
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
Secondary Outcome Measure Information:
Title
The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
caries-free individuals with no clinical evidence of caries experience [decayed, missing and filled teeth (DMFT) = 0] and caries-active individuals (DMFT ≥ 6) were recruited
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Xu, D.D.S
Organizational Affiliation
West China Hospital of Stomatology, Sichuan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ecological Effect of Arginine Dentifrice on Oral Microbiota
We'll reach out to this number within 24 hrs