Dentinal Hypersensitivity Reduction

Dentinal Hypersensitivity Clinical Trial

Official title:

: Clinical Study to Assess the Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to a Commercially-available Potassium-based Toothpaste and a Regular Fluoride Toothpaste (Negative Control) on the Reduction of Dentinal Hypersensitivity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06244290
• Other study ID #: CRO-2020-05-SEN-SNF-CA-BGS
• Status: Completed
• Phase: Phase 3
• Start date: September 28, 2020
• Est. completion date: October 21, 2020

Study information

• Verified date: January 2024
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentinal Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Colgate SNF
toothpaste
• Sensodyne Extra Whitening
toothpaste
• Colgate Fluoride (CDC)
toothpaste

Locations

Country	Name	City	State
United States	Mesa Dental Centre	Costa Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tactile dentin hypersensitivity	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)	Baseline, 1-Day, 3-Days and 7-Days
Primary	Air blast dentin hypersensitivity	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.	Baseline, 1-Day, 3-Days and 7-Days