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OpenTrials
Completed

NCT Number: NCT00758563

Train New Examiners Via Modified Gingival Margin Plaque

The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northampton Community College

Bethlehem, Pennsylvania, 18020, United States

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 for 24-hrs.after initial appointment.
  • 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 can affect salivary flow
  • 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.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Treatment and study plan

Fluoride

Drug

Brush twice daily

Triclosan/Fluoride

Drug

Brush twice daily

Primary outcomes

  1. Mean Gingival Plaque Units

    Time frame: 1 day

    Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 25, 2008
Registry last updated
Nov 25, 2008

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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