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OpenTrials
Completed

NCT Number: NCT01024738

Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

TKL Research, Inc.

Paramus, New Jersey, 07652, United States

About this study

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be aged 18 to 65 years inclusive
  • Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
  • Give written informed consent
  • Be in good general health
  • No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
  • If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion criteria

  • Medical condition which requires pre-medication (antibiotics) prior to dental
  • Visits/procedures
  • Allergy to chlorhexidine
  • Advanced periodontal disease (gum disease)
  • 5 or more decayed, untreated dental sites (cavities)
  • Diseases of the soft or hard oral tissues (gums or palate)
  • Orthodontic appliances that interfere with plaque rating
  • Abnormal salivary function
  • Use of drugs that can affect currently salivary flow or production
  • Use of antibiotics one (1) month prior to or during this study
  • Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
  • Pregnant or breastfeeding.
  • Participation in another research study in the month preceding this study
  • Allergic to common toothpaste or mouth rinse ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes

Treatment and study plan

Fluoride

Drug

Brush half mouth twice daily for four days.

Triclosan, fluoride

Drug

Brush twice daily

Other names: Total toothpaste

Chlorhexidine gluconate

Drug

Rinse mouth twice a day

Primary outcomes

  1. Plaque Index

    Time frame: 4 Days

    Plaque score is Units on a 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
2008
Primary completion
2008
Study completion
2008
First posted
Dec 3, 2009
Registry last updated
Dec 3, 2009

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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