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OpenTrials
Completed

NCT Number: NCT00758394

Clinical Study to Compare Dental Plaque Control

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

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Key information

Age range

18 year–53 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bluestone Center for Clinical Research, NYU College of Dentistry

New York, 10016, United States

About this study

Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

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 - 53 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).
  • 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 are currently affecting salivary function
  • 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 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 any purpose.
  • Presence of an orthodontic appliance which interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • History of allergy to arginine (amino acid)
  • History of allergy to bicarbonate
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Treatment and study plan

Fluoride

Drug

Brush two times a day for 4 days.

Other names: monofluorophosphate

Triclosan/Fluoride

Drug

Brush two times daily for 4 days

Other names: sodium fluoride, triclosan

Primary outcomes

  1. Dental Plaque Index

    Time frame: 4-Day

    plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 25, 2008
Registry last updated
Aug 15, 2013

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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