Ecological Effect of Arginine Dentifrice on Oral Microbiota

NCT02988349 | Completed Results

• 1 other identifier: WCHSIRB-D-2013-067-R2
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries; Oral Bacterial Infection; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays

  baseline ,2 week

Study Arms (2)

Caries-free subjects

ACTIVE COMPARATOR

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Other: Colgate® Sensitive Pro-Relief® toothpaste

Caries-active subjects

EXPERIMENTAL

Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.

Other: Colgate® Sensitive Pro-Relief® toothpaste

Interventions

Colgate® Sensitive Pro-Relief® toothpaste OTHER

Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.

Caries-active subjects; Caries-free subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Xin Xu
• Organization: Sichuan University

xin.xu@scu.edu.cn

86-28-85503494

Study Officials

• Xin Xu, D.D.S

  West China Hospital of Stomatology, Sichuan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 9, 2016
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share