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A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

NCT ID: NCT00964860

Last Updated: 2012-10-31

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-08-31

Brief Summary

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This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.

Detailed Description

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Brushing Only

Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice

Group Type NO_INTERVENTION

No interventions assigned to this group

Brushing + Flossing

Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss

Group Type EXPERIMENTAL

Glide dental floss

Intervention Type DEVICE

Glide waxed dental floss

Interventions

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Glide dental floss

Glide waxed dental floss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

In order to be included in the study, each subject must:

* be at least 18 years of age;
* be physically able to floss their teeth;
* have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
* have refrained from performing oral hygiene the morning of the Baseline visit;
* be in good general health;
* have interproximal MGI (Modified Gingival Index) score of \>2.8.

Exclusion Criteria

Subjects are excluded from study participation where there is evidence of:

* severe periodontal disease;
* discoloration or pigmentation in the gingival tissue;
* meaningful misalignment of front teeth;
* fixed facial orthodontic appliances;
* use of antibiotics within two weeks of the Baseline Visit and at any time during the study;
* any diseases or conditions that could be expected to interfere with the subject safely completing the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Witt, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Radiologio Oral Y Maxilofacial

Guatemala City, , Guatemala

Site Status

Countries

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Guatemala

Other Identifiers

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2009061

Identifier Type: -

Identifier Source: org_study_id