Train New Examiners Via Modified Gingival Margin Plaque
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.
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 Mar 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
March 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 20, 2008
CompletedNovember 25, 2008
November 1, 2008
1 month
September 23, 2008
October 16, 2008
November 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Gingival Plaque Units
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).
1 day
Study Arms (2)
A
PLACEBO COMPARATORB
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
- 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).
- 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 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.
- 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.
- History of allergy to common dentifrice ingredients.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northampton Community College
Bethlehem, Pennsylvania, 18020, 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
Terry Sigal-Greene
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
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
March 1, 2008
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 25, 2008
Results First Posted
November 20, 2008
Record last verified: 2008-11