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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

NCT ID: NCT00926328

Last Updated: 2013-08-15

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Detailed Description

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Conditions

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Gingivitis

Keywords

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Gingivitis and Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A -Experimental toothpaste

triclosan/copolymer/fluoride toothpaste

Group Type ACTIVE_COMPARATOR

Triclosan, fluoride

Intervention Type DRUG

Six Month study, brush twice daily

B - control toothpaste

sodium fluoride only toothpaste (placebo)

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

twice daily usage

Interventions

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Triclosan, fluoride

Six Month study, brush twice daily

Intervention Type DRUG

Fluoride

twice daily usage

Intervention Type DRUG

Other Intervention Names

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Colgate Total Advanced Freshening toothpaste Crest Cavity Protection toothpaste

Eligibility Criteria

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Inclusion Criteria

* Availability for the six-month duration of the study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form.

Exclusion Criteria

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
* periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Use of antibiotics any time during the one month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry
* into the study.
* Pregnant women or women who are breast feeding.
* Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
* History of allergic to personal care/consumer products or their ingredients.
* Taking any prescription medicines. That might interfere with the study outcome.
* Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Responsibility Role SPONSOR

Principal Investigators

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Augusto E Boneta, DDS

Role: PRINCIPAL_INVESTIGATOR

Dental Research Associates

Locations

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Dr. Fernando Autran

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CRO-0507-PL-SP-CT-BS

Identifier Type: -

Identifier Source: org_study_id