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A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste

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ClinicalTrials.gov Identifier: NCT00762151
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Dental Plaque Other: Negative Control (Regular Toothpaste) Other: Positive Control (anti-plaque/anti-bacterial toothpaste) Drug: Prototype (AN0128 Toothpaste) Phase 1

Detailed Description:
The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
Study Start Date : November 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Placebo Comparator: Negative Control
Regular Toothpaste
Other: Negative Control (Regular Toothpaste)
Regular Toothpaste

Active Comparator: Positive Control
Standard anti-plaque and anti-bacterial toothpaste.
Other: Positive Control (anti-plaque/anti-bacterial toothpaste)
Standard anti-plaque and anti-bacterial toothpaste

Active Comparator: Prototype
AN0128 Toothpaste
Drug: Prototype (AN0128 Toothpaste)
AN0128 Toothpaste




Primary Outcome Measures :
  1. Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing) [ Time Frame: Baseline (time zero), 24 hour time point ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Advanced periodontal disease
  • 5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762151


Locations
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United States, New Jersey
Concordia Research Laboratories
Cedar Knolls, New Jersey, United States, 07927
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00762151    
Other Study ID Numbers: AN0128 Periodontal Plaque
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by Pfizer:
Dental Plaque
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents