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

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Negative Control (Regular Toothpaste)
Positive Control (anti-plaque/anti-bacterial toothpaste)
Prototype (AN0128 Toothpaste)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Dental Plaque

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Concordia Research Laboratories

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Negative Control

Positive Control

Prototype

Arm Description

Regular Toothpaste

Standard anti-plaque and anti-bacterial toothpaste.

AN0128 Toothpaste

Outcomes

Primary Outcome Measures

Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)

Secondary Outcome Measures

Full Information

First Posted
September 24, 2008
Last Updated
June 3, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00762151
Brief Title
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Official Title
Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Dental Plaque

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Control
Arm Type
Placebo Comparator
Arm Description
Regular Toothpaste
Arm Title
Positive Control
Arm Type
Active Comparator
Arm Description
Standard anti-plaque and anti-bacterial toothpaste.
Arm Title
Prototype
Arm Type
Active Comparator
Arm Description
AN0128 Toothpaste
Intervention Type
Other
Intervention Name(s)
Negative Control (Regular Toothpaste)
Intervention Description
Regular Toothpaste
Intervention Type
Other
Intervention Name(s)
Positive Control (anti-plaque/anti-bacterial toothpaste)
Intervention Description
Standard anti-plaque and anti-bacterial toothpaste
Intervention Type
Drug
Intervention Name(s)
Prototype (AN0128 Toothpaste)
Intervention Description
AN0128 Toothpaste
Primary Outcome Measure Information:
Title
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Time Frame
Baseline (time zero), 24 hour time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Concordia Research Laboratories
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States

12. IPD Sharing Statement

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

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