Dentinal Hypersensitivity Reduction

NCT06244290 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2020-05-SEN-SNF-CA-BGS
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentinal Hypersensitivity

Keywords

tactile; airblast; dentin hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Group I

ACTIVE COMPARATOR

Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush

Drug: Colgate SNF

Group II

ACTIVE COMPARATOR

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

Drug: Sensodyne Extra Whitening

Group III

PLACEBO COMPARATOR

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

Drug: Colgate Fluoride (CDC)

Interventions

Colgate SNF DRUG

toothpaste

Group I

Sensodyne Extra Whitening DRUG

toothpaste

Group II

Colgate Fluoride (CDC) DRUG

toothpaste

Group III

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Mesa Dental Centre

Costa Mesa, California, 92627, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Centers for Disease Control and Prevention, U.S.

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government; Organizations; Health Care Economics and Organizations

Study Officials

• Farid Ayad, DMD, MSD

  Mesa Dental Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: September 28, 2020
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: March 18, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)