Dentinal Hypersensitivity Reduction

Phase 3

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Drug: Colgate SNF; Drug: Sensodyne Extra Whitening; Drug: Colgate Fluoride (CDC)

• Registration Number: NCT06244290
• Lead Sponsor: Colgate Palmolive

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-09-28
• Primary Completion: 2020-10-21
• Study Completion: 2020-10-21
• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Colgate SNF	Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Group II	Colgate Fluoride (CDC)	Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Group III	Colgate Fluoride (CDC)	Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
Group I	Sensodyne Extra Whitening	Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Group III	Sensodyne Extra Whitening	Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
Group I	Colgate Fluoride (CDC)	Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Group III	Colgate SNF	Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
Group II	Colgate SNF	Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Group II	Sensodyne Extra Whitening	Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush

Primary Outcome Measures

Name	Time	Method
Tactile dentin hypersensitivity	Baseline, 1-Day, 3-Days and 7-Days	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)
Air blast dentin hypersensitivity	Baseline, 1-Day, 3-Days and 7-Days	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.

Trial Locations

Locations (1)

Mesa Dental Centre; 🇺🇸 Costa Mesa, California, United States