Skip to main content
OpenTrials
Completed

NCT Number: NCT01014143

Evaluating Commercial Anti-Plaque Products and Oral Rinse

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Completed

Looking for future studies?

Notify Me

Key information

Age range

23 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Institutional Service Company

Northfield, New Jersey, 08225, United States

About this study

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female volunteers at least 18 years of age.
  • Good general health.
  • Must sign informed consent form.
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • 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

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures.
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus).
  • Two 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 are currently affect salivary function.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Allergy to chlorhexidine.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week 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 pre-medication for dental treatment or for any other purpose.
  • Presence of an orthodontic appliance that interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Treatment and study plan

Fluoride

Drug

Half mouth toothbrushing twice a day for four days.

Other names: fluoride toothpaste

Chlorhexidine digluconate

Drug

Mouth rinsing with 15 ml for 30 seconds twice a day for four days.

Other names: Periogard oral rinse

Fluoride, triclosan

Drug

Half mouth Brushing twice daily

Other names: Total toothpaste

Primary outcomes

  1. Plaque Index

    Time frame: Four days

    Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 16, 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.

Published trials that share one or more normalized conditions with this study.