Dentinal Hypersensitivity Reduction

NCT ID: NCT06244290

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2020-10-21

Brief Summary

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The objective of this clinical study is to assess the efficacy of a dentifrice containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste, GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over a seven (7) day period.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I

Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush

Group Type ACTIVE_COMPARATOR

Colgate SNF

Intervention Type DRUG

toothpaste

Sensodyne Extra Whitening

Intervention Type DRUG

toothpaste

Colgate Fluoride (CDC)

Intervention Type DRUG

toothpaste

Group II

Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush

Group Type ACTIVE_COMPARATOR

Colgate SNF

Intervention Type DRUG

toothpaste

Sensodyne Extra Whitening

Intervention Type DRUG

toothpaste

Colgate Fluoride (CDC)

Intervention Type DRUG

toothpaste

Group III

Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush

Group Type PLACEBO_COMPARATOR

Colgate SNF

Intervention Type DRUG

toothpaste

Sensodyne Extra Whitening

Intervention Type DRUG

toothpaste

Colgate Fluoride (CDC)

Intervention Type DRUG

toothpaste

Interventions

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Colgate SNF

toothpaste

Intervention Type DRUG

Sensodyne Extra Whitening

toothpaste

Intervention Type DRUG

Colgate Fluoride (CDC)

toothpaste

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sign an Informed Consent Form;
* Male or female 18 to 70 years of age, inclusive;
* Be in good general health as determined by the study investigators;
* Available for the seven (7) days duration of the study;
* Must present two (2) sensitive teeth which must meet ALL of the following criteria:

* Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
* Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA);
* Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale

Exclusion Criteria

* Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
* Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
* Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
* Sensitive teeth with a mobility greater than one;
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
* Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics;
* Participation in any other oral clinical study for the duration of this study
* Self-reported pregnancy and/or currently breastfeeding;
* Allergies to oral care products, personal care consumer products, and/or their ingredients;
* Medical condition which prohibits not eating/drinking for 4 hours.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farid Ayad, DMD, MSD

Role: PRINCIPAL_INVESTIGATOR

Mesa Dental Centre

Locations

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Mesa Dental Centre

Costa Mesa, California, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-2020-05-SEN-SNF-CA-BGS

Identifier Type: -

Identifier Source: org_study_id

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