Ecological Effect of Arginine Dentifrice on Oral Microbiota

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.

NCT07149376

Sensitivity, Tooth

COMPLETED PHASE3

Dentinal Hypersensitivity Reduction Efficacy Study

NCT06960148

Sensitivity, Tooth

RECRUITING PHASE3

2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste

NCT05560945

Dental Caries

COMPLETED PHASE3

Oothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity

NCT07257042

Hypersensitivity

COMPLETED PHASE3

A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome

NCT06048809

Oral Health

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries Oral Bacterial Infection Microbiota

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caries-free subjects

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

Group Type ACTIVE_COMPARATOR

Colgate® Sensitive Pro-Relief® toothpaste

Intervention Type 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

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

Group Type EXPERIMENTAL

Colgate® Sensitive Pro-Relief® toothpaste

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes