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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
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 24, 2016
    Last Updated
    April 18, 2018
    Sponsor
    Sichuan University
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    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

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    Ecological Effect of Arginine Dentifrice on Oral Microbiota

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