Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2008-05-31
2008-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Triclosan/Fluoride
Brush twice daily for 3 weeks
B
Fluoride/triclosan
Brush daily for 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Triclosan/Fluoride
Brush twice daily for 3 weeks
Fluoride/triclosan
Brush daily for 3 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
20 Years
51 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Colgate Palmolive
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Colgate Palmolive
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patricia Corby, DDS
Role: PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bluestone Center for Clinical Research, NYU College of Dentistry
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRO-2008-PLA-13-RR
Identifier Type: -
Identifier Source: org_study_id