Dentinal Hypersensitivity Reduction

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dentinal Hypersensitivity

Treatments: Drug: Sensodyne Extra Whitening; Drug: Colgate Fluoride (CDC); Drug: Colgate SNF

Study type: Interventional

Funder types: Industry

Identifiers

NCT06244290

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

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 3 patient groups, including a placebo group

Group I

Active Comparator group

Description:

Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush

Treatment:

Drug: Colgate Fluoride (CDC)

Drug: Sensodyne Extra Whitening

Drug: Colgate SNF

Group II

Active Comparator group

Description:

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

Treatment:

Drug: Colgate Fluoride (CDC)

Drug: Sensodyne Extra Whitening

Drug: Colgate SNF

Group III

Placebo Comparator group

Description:

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

Treatment:

Drug: Colgate Fluoride (CDC)

Drug: Sensodyne Extra Whitening

Drug: Colgate SNF