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Trial record 13 of 256 for:    colgate

Ecological Effect of Arginine Dentifrice on Oral Microbiota

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ClinicalTrials.gov Identifier: NCT02988349
Recruitment Status : Completed
First Posted : December 9, 2016
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Xin Xu, Sichuan University

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.

Condition or disease Intervention/treatment Phase
Dental Caries Oral Bacterial Infection Microbiota Other: Colgate® Sensitive Pro-Relief® toothpaste Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ecological Effect of 8% Arginine Dentifrice on Oral Microbiota of Caries-Free and Caries-active Populations
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Caries-free subjects
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.

Experimental: Caries-active subjects
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.




Primary Outcome Measures :
  1. The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing [ Time Frame: baseline , 2 week ]
    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 :
  1. The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays [ Time Frame: baseline ,2 week ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988349


Sponsors and Collaborators
Sichuan University
Investigators
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Principal Investigator: Xin Xu, D.D.S West China Hospital of Stomatology, Sichuan University

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Responsible Party: Xin Xu, Clinical Professor, Sichuan University
ClinicalTrials.gov Identifier: NCT02988349     History of Changes
Other Study ID Numbers: WCHSIRB-D-2013-067-R2
First Posted: December 9, 2016    Key Record Dates
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sodium Fluoride
Listerine
Dental Caries
Bacterial Infections
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents