Clinical trial NCT04590040: Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Official title: Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Sangi Co., Ltd.
First posted: 2020-10-19
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

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

Primary outcomes:
measure: Measurement of Cold Air Stimulus
timeFrame: Week 0 (baseline), 4 weeks and 8 weeks
Secondary outcomes:
measure: Measurement of Tactile Stimulus
timeFrame: Week 0 (baseline), 4 weeks and 8 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: School of Dentistry, University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Bennett T Amaechi, BDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: