Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

NCT ID: NCT02192307

Last Updated: 2019-11-05

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

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This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

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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potassium oxalate gel

Professional application

Group Type EXPERIMENTAL

Potassium oxalate

Intervention Type DEVICE

Potassium oxalate liquid

Professional application

Group Type ACTIVE_COMPARATOR

Potassium oxalate

Intervention Type DEVICE

Interventions

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Potassium oxalate

Intervention Type DEVICE

Other Intervention Names

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Professional application

Eligibility Criteria

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Inclusion Criteria

* Provide written informed consent to participate in the study
* Be at least 18 years of age
* Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
* Agree to refrain from participating in any other oral/dental product studies for the duration of the study
* Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
* Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
* Agree to comply with study/product usage instructions; and
* Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria

* Gross oral neglect or urgent dental treatment needs
* Severe periodontal disease and/or generalized mobility
* Active treatment for periodontitis
* Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
* Self-reported pregnancy or nursing
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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Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2014047

Identifier Type: -

Identifier Source: org_study_id

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