Investigation of Dental Plaque and Gingival Index

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

Brief Summary

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Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

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Detailed Description

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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

SINGLE

Participants

Study Groups

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A - Marketed fluoride toothpaste

Group Type PLACEBO_COMPARATOR

Sodium Monofluorophosphate

Intervention Type DRUG

Brush teeth and evaluate plaque score after one use of the study toothpaste

B -Triclosan/NaF/CoPolymer toothpaste

Group Type ACTIVE_COMPARATOR

Triclosan/Fluoride/Copolymer

Intervention Type DRUG

Brush teeth and evaluate plaque score after one use of the study toothpaste

Interventions

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Sodium Monofluorophosphate

Brush teeth and evaluate plaque score after one use of the study toothpaste

Intervention Type DRUG

Triclosan/Fluoride/Copolymer

Brush teeth and evaluate plaque score after one use of the study toothpaste

Intervention Type DRUG

Other Intervention Names

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Colgate Great Regular Flavor toothpaste Colgate Total toothpaste

Eligibility Criteria

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Inclusion Criteria

* Be aged 18 to 65 years inclusive
* Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* Must discontinue oral hygiene for 24-hrs.after initial appointment.
* 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

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 currently 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, naproxyn)
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes