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Evaluating the Effect of Tooth Cleaning Devices on Oral Health

NCT ID: NCT01250769

Last Updated: 2012-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.

Detailed Description

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Conditions

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Dental Plaque

Keywords

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dental dentist plaque IP Cleaning

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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Manual Toothbrush 1

Manual Toothbrush used for 1 minute twice a day

Group Type ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type DEVICE

A standard size manual toothbrush to clean visible tooth surfaces

Manual Toothbrush 2

Manual Toothbrush used for 2 minutes twice a day

Group Type ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type DEVICE

A standard size manual toothbrush to clean visible tooth surfaces

Manual Toothbrush + Interproximal Cleaning 1

Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day

Group Type EXPERIMENTAL

Manual Toothbrush

Intervention Type DEVICE

A standard size manual toothbrush to clean visible tooth surfaces

Interproximal Cleaning Device

Intervention Type DEVICE

An electronic device that combines water and air to clean between the teeth

Manual Toothbrush + Interproximal Cleaning 2

Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day

Group Type EXPERIMENTAL

Manual Toothbrush

Intervention Type DEVICE

A standard size manual toothbrush to clean visible tooth surfaces

Interproximal Cleaning Device

Intervention Type DEVICE

An electronic device that combines water and air to clean between the teeth

Interventions

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Manual Toothbrush

A standard size manual toothbrush to clean visible tooth surfaces

Intervention Type DEVICE

Interproximal Cleaning Device

An electronic device that combines water and air to clean between the teeth

Intervention Type DEVICE

Other Intervention Names

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ADA Reference Toothbrush Philips AirFloss

Eligibility Criteria

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Inclusion Criteria

* are in good/excellent health;
* are 18 - 70 years old;
* have a minimum of 20 natural teeth (excluding 3rd molars);
* have sufficient test sites;
* have ≥ 20 bleeding sites;
* are willing to participate and available for participation.

Exclusion Criteria

* have systemic diseases such as Down's syndrome, or known AIDS/HIV;
* have insulin dependant Diabetes;
* are pregnant or nursing by subject report;
* have a cardiac pacemaker
* are undergoing or require extensive dental or orthodontic treatment;
* require antibiotic treatment for dental appointments;
* have heavy deposits of calculus;
* have severe gingivitis or periodontitis;
* have extensive crown or bridge work and/or rampant decay;
* currently use bleaching trays;
* have any oral or extraoral piercing on lips or in mouth;
* have a professional prophylaxis within 4 weeks of study;
* participation in a prior study ≤ 20 days;
* employed by a oral healthcare products company or research institution.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Oral Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Jenkins

Role: STUDY_DIRECTOR

POHC

Locations

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University Park Research Center

Fort Wayne, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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DRC-0703

Identifier Type: -

Identifier Source: org_study_id