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Investigation of Dental Plaque and Gingival Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00759031
First received: September 23, 2008
Last updated: April 11, 2012
Last verified: April 2012
History of Changes

September 23, 2008
April 11, 2012
February 2008
March 2008   (final data collection date for primary outcome measure)
Gingival Margin Plaque Index [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
Mean gingival plaque scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00759031 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Investigation of Dental Plaque and Gingival Index
Investigation of Dental Plaque and Gingival Index

Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dental Plaque
  • Drug: Sodium Monofluorophosphate
    Brush teeth and evaluate plaque score after one use of the study toothpaste
    Other Name: Colgate Great Regular Flavor toothpaste
  • Drug: Triclosan/Fluoride/Copolymer
    Brush teeth and evaluate plaque score after one use of the study toothpaste
    Other Name: Colgate Total toothpaste
  • Placebo Comparator: A - Marketed fluoride toothpaste
    Intervention: Drug: Sodium Monofluorophosphate
  • Active Comparator: B -Triclosan/NaF/CoPolymer toothpaste
    Intervention: Drug: Triclosan/Fluoride/Copolymer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
March 2008
March 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759031
CRO-2007-PLA-23-RR
No
Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Patricia Corby, DDS
Colgate Palmolive
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP