Ecological Effect of Arginine Dentifrice on Oral Microbiota

Ecological Effect of 8% Arginine Dentifrice on Oral Microbiota of Caries-Free and Caries-active Populations

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Oral Bacterial Infection; Microbiota
• Intervention / Treatment: Other: Colgate® Sensitive Pro-Relief® toothpaste

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sichuan University
• Investigators: Principal Investigator: Xin Xu, D.D.S, West China Hospital of Stomatology, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Bacterial Infections and Mycoses; Tooth Demineralization; Tooth Diseases; Dental Caries; Bacterial Infections; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: WCHSIRB-D-2013-067-R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No