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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Dental Plaque

Treatments: Other: Positive Control (anti-plaque/anti-bacterial toothpaste); Other: Negative Control (Regular Toothpaste); Drug: Prototype (AN0128 Toothpaste)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762151

AN0128 Periodontal Plaque

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 3 patient groups, including a placebo group

Negative Control

Placebo Comparator group

Description:

Regular Toothpaste

Treatment:

Other: Negative Control (Regular Toothpaste)

Positive Control

Active Comparator group

Description:

Standard anti-plaque and anti-bacterial toothpaste.

Treatment:

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

Prototype

Active Comparator group

Description:

AN0128 Toothpaste

Treatment:

Drug: Prototype (AN0128 Toothpaste)