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Arginine Plaque Metabolism Pilot Clinical Study

Colgate-Palmolive logo

Colgate-Palmolive

Status and phase

Completed
Phase 3

Conditions

Plaque, Dental

Treatments

Drug: TOM's Superior Sensitivity Relief Toothpaste
Drug: Colgate Cavity Protection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06954779
CRO-2023-SAL-05-EG

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Test 1 toothpaste
Active Comparator group
Description:
fluoride toothpaste
Treatment:
Drug: Colgate Cavity Protection
Test 2 toothpaste
Experimental group
Description:
non fluoride toothpaste
Treatment:
Drug: TOM's Superior Sensitivity Relief Toothpaste

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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