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

NCT ID: NCT01024738

Last Updated: 2009-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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

Conditions

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluoride toothpaste

negative control toothpaste

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush half mouth twice daily for four days.

Triclosan/Fluoride toothpaste

positive control toothpaste (Total toothpaste)

Group Type ACTIVE_COMPARATOR

Triclosan, fluoride

Intervention Type DRUG

Brush twice daily

Chlorhexidine Oral Rinse

positive control oral rinse

Group Type ACTIVE_COMPARATOR

Chlorhexidine Gluconate

Intervention Type DRUG

Rinse mouth twice a day

Interventions

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Fluoride

Brush half mouth twice daily for four days.

Intervention Type DRUG

Triclosan, fluoride

Brush twice daily

Intervention Type DRUG

Chlorhexidine Gluconate

Rinse mouth twice a day

Intervention Type DRUG

Other Intervention Names

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Total toothpaste

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Colgate Palmolive

Principal Investigators

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Mark LeFelt, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

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TKL Research, Inc.

Paramus, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-2008-PLA-05-RR

Identifier Type: -

Identifier Source: org_study_id