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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.