You are here

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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Concordia Research Laboratories
Cedar Knolls, New Jersey, 07927 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dental Plaque
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00762151
Pfizer
Completed
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Chronic Plaque Psoriasis
NCT02969018
All Genders
18+
Years
Multiple Sites
Postoperative Dental Pain
NCT01529346
All Genders
18+
Years
Multiple Sites
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
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.
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.
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Dental Plaque
  • Other: Negative Control (Regular Toothpaste)
    Regular Toothpaste
  • Other: Positive Control (anti-plaque/anti-bacterial toothpaste)
    Standard anti-plaque and anti-bacterial toothpaste
  • Drug: Prototype (AN0128 Toothpaste)
    AN0128 Toothpaste
  • Placebo Comparator: Negative Control
    Regular Toothpaste
    Intervention: Other: Negative Control (Regular Toothpaste)
  • Active Comparator: Positive Control
    Standard anti-plaque and anti-bacterial toothpaste.
    Intervention: Other: Positive Control (anti-plaque/anti-bacterial toothpaste)
  • Active Comparator: Prototype
    AN0128 Toothpaste
    Intervention: Drug: Prototype (AN0128 Toothpaste)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00762151
AN0128 Periodontal Plaque
No
Not Provided
Not Provided
Kirk R Maples, PhD, Anacor Pharmaceuticals, Inc.
Pfizer
Not Provided
Study Director: Kirk R Maples, PhD Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now