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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014