Dentin Hypersensitivity Reduction Efficacy Clinical

NCT07738198 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2018-10-SEN-SNRR-ED
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess clinical efficacy of a toothpaste containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to commercially available potassium-based desensitizing toothpaste (Senodyne Extra Whitening Toothpaste, GasoSmithKline Co., UK) and commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) over a seven day study period

Conditions

Dental Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe

  Tactile sensitivity will be assessed by use of Sensing Probe Yeaple Electronic Force Sensing Probe, Model 200A. Sensitivity will be defined by a score in the range of 10-50 gms. of force.

  baseline, 1 day, 3 day, 7 day

• Air Sensitivity using the Schiff Cold Air Sensitivity Scale

  The air will be directed at the exposed buccal surface of the sensitive tooth air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F\[± 3°F\].

  baseline, 1 day, 3 day, 7 day

Study Arms (3)

Test 1 toothpaste

EXPERIMENTAL

Drug: 0.454% stannous fluoride toothpaste

Test 2 toothpaste

ACTIVE COMPARATOR

Drug: 5% potassium nitrate

Test 3 toothpaste

ACTIVE COMPARATOR

Drug: 0.76% sodium monofluorophosphate

Interventions

0.454% stannous fluoride toothpaste DRUG

brush twice daily (morning and evening) Duration of exposure: one (1) minute

Test 1 toothpaste

5% potassium nitrate DRUG

Brush twice daily (morning and evening) Duration of exposure: one (1) minute

Test 2 toothpaste

0.76% sodium monofluorophosphate DRUG

Brush twice daily (morning and evening) Duration of exposure: one (1) minute

Test 3 toothpaste

Eligibility Criteria

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

You may qualify if:

• Must be male or female 18 to 70 years of age
• Must give written informed consent
• Must be in good general health as determined by the study investigators
• Must be available for the seven day duration of the study
• Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion 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:

• Allergies to oral care products, personal care consumer products, or their ingredients.
• Use of a desensitizing oral care product or recipient of desensitizing treatment within three months prior to start of the study.
• Gross oral pathology, advanced periodontal disease 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 studies for the duration of this study
• Full or partial removable oral prostheses
• Pregnant or lactating (breast feeding)
• Allergies to oral care products, personal care consumer products, or their ingredients.
• Medical condition which prohibits not eating/drinking for 4 hours

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

FAR Oral and Systemic Health Consulting, Inc

Costa Mesa, California, 92627, United States

Location

MeSH Terms

Interventions

potassium nitrate; fluorophosphate

Study Officials

• Farid Ayad

  FAR ORAL SYSTEMIC HEALTH CONSULTING INC.

  PRINCIPAL INVESTIGATOR

• Maha Hetata

  FAR ORAL SYSTEMIC HEALTH CONSULTING INC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 31, 2026
• Study Start: November 26, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)