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

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00762151
First received: September 24, 2008
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing) [ Time Frame: Baseline (time zero), 24 hour time point ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Prototype (AN0128 Toothpaste)
AN0128 Toothpaste

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762151

Locations
United States, New Jersey
Concordia Research Laboratories
Cedar Knolls, New Jersey, United States, 07927
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Kirk R Maples, PhD Anacor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Kirk R Maples, PhD, Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00762151     History of Changes
Other Study ID Numbers: AN0128 Periodontal Plaque
Study First Received: September 24, 2008
Last Updated: September 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:
Dental Plaque

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014