Study Results
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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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2020-09-28
2020-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group I
Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Colgate SNF
toothpaste
Sensodyne Extra Whitening
toothpaste
Colgate Fluoride (CDC)
toothpaste
Group II
Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Colgate SNF
toothpaste
Sensodyne Extra Whitening
toothpaste
Colgate Fluoride (CDC)
toothpaste
Group III
Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
Colgate SNF
toothpaste
Sensodyne Extra Whitening
toothpaste
Colgate Fluoride (CDC)
toothpaste
Interventions
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Colgate SNF
toothpaste
Sensodyne Extra Whitening
toothpaste
Colgate Fluoride (CDC)
toothpaste
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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CRO-2020-05-SEN-SNF-CA-BGS
Identifier Type: -
Identifier Source: org_study_id
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