Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque

Treatments: Drug: Fluoride; Drug: Triclosan, fluoride; Drug: Chlorhexidine Gluconate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024738

CRO-2008-PLA-05-RR

Details and patient eligibility

About

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Full description

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be aged 18 to 65 years inclusive
• Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
• Give written informed consent
• Be in good general health
• No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
• If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion criteria

• Medical condition which requires pre-medication (antibiotics) prior to dental
• Visits/procedures
• Allergy to chlorhexidine
• Advanced periodontal disease (gum disease)
• 5 or more decayed, untreated dental sites (cavities)
• Diseases of the soft or hard oral tissues (gums or palate)
• Orthodontic appliances that interfere with plaque rating
• Abnormal salivary function
• Use of drugs that can affect currently salivary flow or production
• 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,naproxyn)
• Pregnant or breastfeeding.
• Participation in another research study in the month preceding this study
• Allergic to common toothpaste or mouth rinse ingredients.
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

Fluoride toothpaste

Placebo Comparator group

Description:

negative control toothpaste

Treatment:

Drug: Fluoride

Triclosan/Fluoride toothpaste

Active Comparator group

Description:

positive control toothpaste (Total toothpaste)

Treatment:

Drug: Triclosan, fluoride

Chlorhexidine Oral Rinse

Active Comparator group

Description:

positive control oral rinse

Treatment:

Drug: Chlorhexidine Gluconate