A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

NCT ID: NCT02221349

Last Updated: 2020-09-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

Brief Summary

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This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

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

DOUBLE

Participants Investigators

Study Groups

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oxalate liquid & gel plus SnF2 paste

Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied

Group Type OTHER

Potassium oxalate

Intervention Type DEVICE

Professionally applied (liquid) and self applied (gel)

Stannous fluoride paste

Intervention Type DRUG

Toothpaste used by subject

oxalate liquid & gel plus NaF paste

Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied

Group Type OTHER

Potassium oxalate

Intervention Type DEVICE

Professionally applied (liquid) and self applied (gel)

Sodium fluoride paste

Intervention Type DRUG

Toothpaste used by subject

Interventions

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Potassium oxalate

Professionally applied (liquid) and self applied (gel)

Intervention Type DEVICE

Sodium fluoride paste

Toothpaste used by subject

Intervention Type DRUG

Stannous fluoride paste

Toothpaste used by subject

Intervention Type DRUG

Other Intervention Names

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NaF paste SnF2 paste

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 confidentiality disclosure agreement
* Be in good general health as determined by the Investigator/designee
* Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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
* Fixed facial orthodontic appliances
* A history of kidney stones
* Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
* Any diseases or conditions that might interfere with the safe completion of the study
* 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

Principal Investigators

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Chad J Anderson, MS, DMD

Role: PRINCIPAL_INVESTIGATOR

Chad J Anderson DMD Inc

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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2014069

Identifier Type: -

Identifier Source: org_study_id

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