Evaluate Clinical Research From Commerical Oral Care Products
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedResults Posted
Study results publicly available
November 18, 2008
CompletedMarch 4, 2010
November 1, 2008
3 months
September 23, 2008
October 16, 2008
February 24, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Dental Plaque Index
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
4-Day
Study Arms (3)
A
PLACEBO COMPARATORB
ACTIVE COMPARATORC
ACTIVE COMPARATORInterventions
Half mouth toothbrushing twice daily for 4 days
Mouth rinsing twice a day for 4 days
Eligibility Criteria
You may qualify if:
- Male or female volunteers 18-65 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.
You may not qualify if:
- 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) requiring more than one visit of cleaning sessions
- 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 can currently affect salivary flow.
- 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.
- Allergy to chlorhexidine
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University School of Dental Medicine
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William DeVizio- DMD
- Organization
- Colgate Palmolive
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Van Dyke, DDS
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
January 1, 2008
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
March 4, 2010
Results First Posted
November 18, 2008
Record last verified: 2008-11