CompletedInterventionalPhase 4Updated Mar 30, 2016
Clinical Study to Evaluate Dental Plaque | NCT00758290 | Trialant
CompletedInterventionalPhase 3Updated Nov 25, 2008
Clinical Study to Evaluate Dental Plaque
Clinical Study to Evaluate Dental Plaque
ClinicalTrials.gov ID
NCT00758290
Lead Sponsor
Colgate PalmoliveINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
23Actual
Last Update Posted
Nov 25, 2008Estimated
Start Date
May 2008
Primary Completion Date
Jul 2008Actual
Completion Date
Jul 2008Actual
Official Title
Clinical Study to Evaluate Dental Plaque
Brief Summary
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
Gingival Diseases
Triclosan/Fluoride
Fluoride/triclosan
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Male or female volunteers at least 20 - 51 years of age
Good general health
Must sign informed consent form
Minimum of 15 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)
5 or more decayed untreated dental sites at screening (cavities)
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 are currently affecting salivary function
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 which interferes with plaque scoring
History of allergy to common toothpaste ingredients
History of allergy to arginine (amino acid)
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
No central contacts
There are no central contacts for this study.
Bluestone Center for Clinical Research, NYU College of Dentistry