Investigation of Dental Plaque and Gingival Index

Colgate Palmolive1 site in 1 country19 target enrollmentFebruary 2008

ConditionsDental Plaque

InterventionsSodium Monofluorophosphate Triclosan/Fluoride/Copolymer

DrugsSodium Monofluorophosphate Triclosan/Fluoride/Copolymer

Overview

Phase: Phase 3
Intervention: Sodium Monofluorophosphate
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Enrollment: 19
Locations: 1
Primary Endpoint: Gingival Margin Plaque Index
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

March 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Colgate Palmolive

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

A - Marketed fluoride toothpaste

Intervention: Sodium Monofluorophosphate

B -Triclosan/NaF/CoPolymer toothpaste

Intervention: Triclosan/Fluoride/Copolymer

Outcomes

Primary Outcomes

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.