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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Plaque

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Negative Control

Regular Toothpaste

Group Type PLACEBO_COMPARATOR

Negative Control (Regular Toothpaste)

Intervention Type OTHER

Regular Toothpaste

Positive Control

Standard anti-plaque and anti-bacterial toothpaste.

Group Type ACTIVE_COMPARATOR

Positive Control (anti-plaque/anti-bacterial toothpaste)

Intervention Type OTHER

Standard anti-plaque and anti-bacterial toothpaste

Prototype

AN0128 Toothpaste

Group Type ACTIVE_COMPARATOR

Prototype (AN0128 Toothpaste)

Intervention Type DRUG

AN0128 Toothpaste

Interventions

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Negative Control (Regular Toothpaste)

Regular Toothpaste

Intervention Type OTHER

Positive Control (anti-plaque/anti-bacterial toothpaste)

Standard anti-plaque and anti-bacterial toothpaste

Intervention Type OTHER

Prototype (AN0128 Toothpaste)

AN0128 Toothpaste

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes