A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
1 other identifier
interventional
18
1 country
1
Brief Summary
The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2007
Shorter than P25 for phase_1
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
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedJune 5, 2019
June 1, 2019
2 months
September 24, 2008
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Baseline (time zero), 24 hour time point
Study Arms (3)
Negative Control
PLACEBO COMPARATORRegular Toothpaste
Positive Control
ACTIVE COMPARATORStandard anti-plaque and anti-bacterial toothpaste.
Prototype
ACTIVE COMPARATORAN0128 Toothpaste
Interventions
Standard anti-plaque and anti-bacterial toothpaste
Eligibility Criteria
You may qualify if:
- Must be between ages 18 to 65 years inclusive
- Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
- Must give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hours after initial appointment
- No known 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:
- Medical condition which requires pre-medication prior to dental visits/procedures
- Advanced periodontal disease
- or more decayed, untreated dental sites
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
- Abnormal salivary function
- Use of drugs that can affect salivary flow
- Use of antibiotics one (1) month prior to or during this study
- Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff
- Pregnant or breastfeeding
- Participation in another clinical study in the month preceding this study
- Allergic to common dentifrice ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- History of allergic reaction to any anti-inflammatory agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Concordia Research Laboratories
Cedar Knolls, New Jersey, 07927, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 30, 2008
Study Start
November 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
June 5, 2019
Record last verified: 2019-06