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Investigation of Dental Plaque and Gingival Index

Colgate-Palmolive logo

Colgate-Palmolive

Status and phase

Completed
Phase 3

Conditions

Dental Plaque

Treatments

Drug: Triclosan/Fluoride/Copolymer
Drug: Sodium Monofluorophosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00759031
CRO-2007-PLA-23-RR

Details and patient eligibility

About

Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

19 participants in 2 patient groups, including a placebo group

A - Marketed fluoride toothpaste
Placebo Comparator group
Treatment:
Drug: Sodium Monofluorophosphate
B -Triclosan/NaF/CoPolymer toothpaste
Active Comparator group
Treatment:
Drug: Triclosan/Fluoride/Copolymer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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