You are here

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

Last updated on November 9, 2019

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 Representative

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 city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Official Title  ICMJE Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
Brief SummaryThe 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 DescriptionThe 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dental Plaque
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion DateJanuary 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762151
Other Study ID Numbers  ICMJE AN0128 Periodontal Plaque
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now