- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758394
Clinical Study to Compare Dental Plaque Control
August 8, 2013 updated by: Colgate Palmolive
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Bluestone Center for Clinical Research, NYU College of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 53 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female volunteers at least 18 - 53 years of age
- Good general health
- Must sign informed consent form
- Minimum of 20 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).
- 2 or more decayed untreated dental sites at screening.
- 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 dentifrice ingredients.
- History of allergy to arginine (amino acid)
- History of allergy to bicarbonate
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Fluoride - A
Fluoride only toothpaste
|
Brush two times a day for 4 days.
Other Names:
|
Active Comparator: Total + Whitening toothpaste - B
Triclosan/fluoride toothpaste
|
Brush two times daily for 4 days
Other Names:
Brush twice daily for 4 days
Other Names:
|
Experimental: Triclosan/fluoride/Amino Acid - C
toothpaste containing amino acid #1
|
Brush two times daily for 4 days
Other Names:
Brush twice daily for 4 days
Other Names:
|
Experimental: Triclosan/fluoride/Cavistat -D
toothpaste containing amino acid/bicarbonate
|
Brush two times daily for 4 days
Other Names:
Brush twice daily for 4 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental Plaque Index
Time Frame: 4-Day
|
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
|
4-Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 23, 2008
First Submitted That Met QC Criteria
September 23, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
August 15, 2013
Last Update Submitted That Met QC Criteria
August 8, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Tooth Diseases
- Dental Deposits
- Dental Plaque
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antimetabolites
- Protective Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Cariostatic Agents
- Fatty Acid Synthesis Inhibitors
- Listerine
- Fluorides
- Sodium Fluoride
- Fluorophosphate
- Triclosan
Other Study ID Numbers
- CRO-0907-PLA-14-RR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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