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

Dental Plaque Clinical Trial

Official title:

Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762151
• Other study ID #: AN0128 Periodontal Plaque
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Est. completion date: January 2008

Study information

• Verified date: June 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Other:
• Negative Control (Regular Toothpaste)
Regular Toothpaste
• Positive Control (anti-plaque/anti-bacterial toothpaste)
Standard anti-plaque and anti-bacterial toothpaste

Drug:
• Prototype (AN0128 Toothpaste)
AN0128 Toothpaste

Locations

Country	Name	City	State
United States	Concordia Research Laboratories	Cedar Knolls	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)		Baseline (time zero), 24 hour time point