Clinical trial NCT06244290: Dentinal Hypersensitivity Reduction
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentinal Hypersensitivity
Keywords: tactile
airblast
dentin hypersensitivity
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tactile dentin hypersensitivity
timeFrame: Baseline, 1-Day, 3-Days and 7-Days
measure: Air blast dentin hypersensitivity
timeFrame: Baseline, 1-Day, 3-Days and 7-Days
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Mesa Dental Centre
state: California
Study officials:
affiliation: Mesa Dental Centre
name: Farid Ayad, DMD, MSD
role: PRINCIPAL_INVESTIGATOR
References: