A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes

NCT ID: NCT02513212

Last Updated: 2020-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-09-30

Brief Summary

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This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

Detailed Description

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Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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oxalate liquid, SnF2 paste, manual toothbrush

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush

Group Type OTHER

Potassium Oxalate

Intervention Type DEVICE

Professionally applied liquid

Stannous fluoride paste

Intervention Type DRUG

SnF2 Paste

Manual toothbrush

Intervention Type DEVICE

Marketed manual toothbrush

oxalate liquid, SnF2 paste, power toothbrush

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

Group Type OTHER

Potassium Oxalate

Intervention Type DEVICE

Professionally applied liquid

Stannous fluoride paste

Intervention Type DRUG

SnF2 Paste

Power toothbrush

Intervention Type DEVICE

Marketed power toothbrush

Interventions

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Potassium Oxalate

Professionally applied liquid

Intervention Type DEVICE

Stannous fluoride paste

SnF2 Paste

Intervention Type DRUG

Manual toothbrush

Marketed manual toothbrush

Intervention Type DEVICE

Power toothbrush

Marketed power toothbrush

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* be at least 18 years of age;
* provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
* be in good general health as determined by the Investigator/designee; and
* have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.

Exclusion Criteria

* self-reported pregnancy or nursing;
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* active treatment of periodontitis;
* any diseases or conditions that might interfere with the safe completion of the study; or
* an inability to undergo any study procedures.
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

Locations

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Chad J Anderson DMD Inc

Fresno, California, United States

Site Status

Countries

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United States

Other Identifiers

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2015059

Identifier Type: -

Identifier Source: org_study_id

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