A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

NCT ID: NCT03405259

Last Updated: 2019-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-26

Study Completion Date

2013-09-13

Brief Summary

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The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.

Detailed Description

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Conditions

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Dentinal Hypersensitivity

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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Super Seal® Desensitizer

Professionally Applied

Group Type EXPERIMENTAL

Super Seal® Desensitizer

Intervention Type DEVICE

Single dose professional application.

Acclean® Fluoride Varnish

Professionally Applied

Group Type SHAM_COMPARATOR

Acclean® Fluoride Varnish

Intervention Type DEVICE

Single dose professional application.

Interventions

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Super Seal® Desensitizer

Single dose professional application.

Intervention Type DEVICE

Acclean® Fluoride Varnish

Single dose professional application.

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;
* be in good general health as determined by the Investigator/designee; and
* have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.

Exclusion Criteria

* allergy to rosin or to pine nuts;
* self-reported pregnancy or nursing;
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* active treatment for periodontitis;
* fixed facial orthodontic appliances;
* 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

Other Identifiers

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2013077

Identifier Type: -

Identifier Source: org_study_id

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