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Investigation of Dental Plaque and Gingival Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00759031
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 25, 2008
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Description
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Brief Summary:
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Sodium Monofluorophosphate Drug: Triclosan/Fluoride/Copolymer Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of Dental Plaque and Gingival Index
Study Start Date : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: A - Marketed fluoride toothpaste Drug: Sodium Monofluorophosphate
Brush teeth and evaluate plaque score after one use of the study toothpaste
Other Name: Colgate Great Regular Flavor toothpaste
Active Comparator: B -Triclosan/NaF/CoPolymer toothpaste Drug: Triclosan/Fluoride/Copolymer
Brush teeth and evaluate plaque score after one use of the study toothpaste
Other Name: Colgate Total toothpaste


Outcome Measures
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Primary Outcome Measures :
  1. Gingival Margin Plaque Index [ 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). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be aged 18 to 65 years inclusive
  • Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
  • Give written informed consent
  • Be in good general health
  • Must discontinue oral hygiene for 24-hrs.after initial appointment.
  • 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

Exclusion Criteria:

  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Advanced periodontal disease
  • 5 or more decayed, untreated dental sites
  • Diseases of the soft or hard oral tissues
  • Orthodontic appliances
  • Abnormal salivary function
  • Use of drugs that can currently affect salivary flow
  • 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 clinical study in the month preceding this study
  • Allergic to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759031


Locations
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United States, New York
Boston University School of Dental Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Patricia Corby, DDS
More Information
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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00759031    
Other Study ID Numbers: CRO-2007-PLA-23-RR
First Posted: September 25, 2008    Key Record Dates
Results First Posted: November 25, 2008
Last Update Posted: April 13, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Listerine
Triclosan
Fluorides
Sodium Fluoride
Fluorophosphate
Cariostatic Agents
 Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents