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OpenTrials
Completed

NCT Number: NCT00981825

Efficacy of Salivary Bacteria and Post Brushing

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

India GTC, Colgate Palmolive(I) ltd

Mumbai, India

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
  • No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion criteria

  • Medical condition which requires pre-medication prior to dental procedures/visits
  • Medical condition which precludes eating/drinking for 12 hrs.
  • History of allergy to common dentifrice ingredients
  • Subjects unable or unwilling to sign the informed consent form.
  • Moderate or advanced periodontal disease.
  • 2 or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that can currently affect salivary flow
  • Current use of antibiotics
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 30 days prior to enrollment into this study.
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)

Treatment and study plan

Fluoride

Drug

Whole mouth brushing for 7 days

Other names: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)

Triclosan/Fluoride

Drug

Brush whole mouth twice daily for 7 days

Other names: triclosan/fluoride toothpaste (Colgate Total toothpaste)

Primary outcomes

  1. CFU (Colony Forming Units)

    Time frame: 4 hours

    Total number of salivary bacterial colony forming units (lower number = less colonies present)

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2009
Registry last updated
Jun 14, 2011

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.