Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity

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.

Condition

  • Dentin Sensitivity

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)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Toothpaste 1 		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
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 3 		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

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Detailed Description

This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.