Purpose

Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.

Category

IRB Number
20190535HU
NCT Number
NCT04590040
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Local Recruitment Point of Contact
Betty Perozo
(210) 567-3452
perozob@uthscsa.edu

Principal Investigator
Bennett Amaechi

Regulatory Point of Contact
Betty Perozo
(210) 567-3452
perozob@uthscsa.edu



Eligibility

Eligible Ages
Between 20 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

    • Males or females between the age of 20 and 80 years, of any socio-economic status
    • Diagnosed as having DHS, i.e. having at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
    • Showing a sensitivity response to both tactile and cold air stimulus delivered by a Yeaple probe and a one-second blast of cold air respectively
    • Patients must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions
    • Patients must be able to read, comprehend, and sign the informed consent form
    • The teeth and sites to be tested should be on the buccal/labial surfaces of incisors, canines, premolars or molars where the affected sites are accessible
    • Teeth selected for testing should have a plaque index of ≤ 2

Exclusion Criteria

    • The sensitive tooth is associated with concomitant oral pain due to any other condition such as soft-tissue lesions, tooth-ache ascribable to dental caries, tooth fracture, or cracked tooth syndrome, or pain due to other surgical procedures or injuries.
    • The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth
    • The sensitive tooth is associated with mobility >1
    • The sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns
    • Patients having pain from periodontal-related causes but not DHS
    • Previous professional desensitizing treatment
    • Patients using medication which could interfere with the perception of pain
    • Medical histories marked by chronic use of anti-inflammatory agents, daily analgesics, anticonvulsants, antihistamines, antidepressants, sedatives and/or other psychotropic drugs
    • Pregnancy or breastfeeding
    • Allergies and idiosyncratic responses to toothpaste ingredients
    • Eating disorders or conditions associated with vomiting
    • Systemic conditions that are etiologic or predisposing to DHS
    • Excessive dietary or environmental exposure to acids
    • The sensitive tooth was restored in the preceding three months
    • The sensitive tooth is an abutment tooth for fixed or removable prostheses
    • The sensitive tooth has extensive restoration or restorations extending into the test area
    • Patients below 20 years or above 80 years of age
    • Smokers

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Condition
  • Dentin Sensitivity
  • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Toothpaste 2

    Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
  • Device: 15% nano-HAP toothpaste

    Toothpaste with identical base formulation as the placebo containing 15% nano-HAP

    Other names:

    • 15 % nano-Hydroxyapatite toothpaste

  • Placebo Comparator

    Toothpaste 1

    Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
  • Other: Placebo

    0% nano-HAP toothpaste

    Other names:

    • Placebo toothpaste

  • Active Comparator

    Toothpaste 3

    Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
  • Device: 5% KNO3 toothpaste

    Toothpaste with identical base formulation as the placebo containing 5% KNO3

    Other names:

    • 5% Potassium Nitrate Toothpaste