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Efficacy of Salivary Bacteria and Post Brushing

Colgate-Palmolive logo

Colgate-Palmolive

Status and phase

Completed
Phase 3

Conditions

Salivary Bacteria Levels

Treatments

Drug: Triclosan/Fluoride
Drug: Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00981825
ER0-2007-SAL-01-GX

Details and patient eligibility

About

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

Enrollment

22 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

22 participants in 2 patient groups, including a placebo group

A
Placebo Comparator group
Description:
fluoride toothpaste control
Treatment:
Drug: Fluoride
B
Active Comparator group
Description:
triclosan/fluoride toothpaste
Treatment:
Drug: Triclosan/Fluoride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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