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OpenTrials
Completed

NCT Number: NCT06954779

Arginine Plaque Metabolism Pilot Clinical Study

Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Volpe Clinical Center

Piscataway, New Jersey, 08854, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent Form.
  • Male and female subjects aged 18-70 years, inclusive.
  • Availability for the nine-week duration of the clinical research study.
  • Good general health based on the opinion of the study investigator
  • Good general health

Exclusion criteria

  • Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
  • Five or more carious lesions requiring immediate care.
  • Concurrent participation in any other oral care clinical study or test panel.
  • Self-reported pregnant or lactating women.
  • Dental prophylaxis received in the past four weeks prior to baseline examinations
  • History of tobacco use-smoking, vaping and chewing tobacco
  • Presence of orthodontic bands, presence of partial removable dentures
  • Tumor(s) of the soft or hard tissues of the oral cavity
  • Use of antibiotics or stain inducing medications any time during the two month prior to entry into the study
  • Use of oral care products containing antimicrobials (Zn, Sn, CPC, triclosan, alcohol containing mouthwash, etc

Treatment and study plan

Colgate Cavity Protection

Drug

1000ppm fluoride

TOM's Superior Sensitivity Relief Toothpaste

Drug

fluoride free

Primary outcomes

  1. Plaque collection

    Time frame: baseline, week 3, week 4, week 6, week 7, week 8, week 9

    Fasting plaque will be collected before and after a sucrose rinse for lactic acid analysis and ammonia production.The plaque pH of collected samples will also be measured to provide trend data.

Secondary outcomes

  1. Saliva collection

    Time frame: week 5 and week 9

    Differences in the arginine concentration in saliva pre- and post-brushing with treatment. Differences in microbiome composition and activity

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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