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

Phase 1

Completed

• Conditions: Dental Plaque
• Interventions: Drug: Prototype (AN0128 Toothpaste); Other: Negative Control (Regular Toothpaste); Other: Positive Control (anti-plaque/anti-bacterial toothpaste)

• Registration Number: NCT00762151
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prototype	Prototype (AN0128 Toothpaste)	AN0128 Toothpaste
Negative Control	Negative Control (Regular Toothpaste)	Regular Toothpaste
Positive Control	Positive Control (anti-plaque/anti-bacterial toothpaste)	Standard anti-plaque and anti-bacterial toothpaste.

Primary Outcome Measures

Name	Time	Method
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)	Baseline (time zero), 24 hour time point

Trial Locations

Locations (1)

Concordia Research Laboratories; 🇺🇸 Cedar Knolls, New Jersey, United States