Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Dentin Sensitivity
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
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
Sites / Locations
- School of Dentistry, University of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Toothpaste 1
Toothpaste 2
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.
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.
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.