N/A
N=192
Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT04590040 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Measurement of Cold Air Stimulus — 71.4; 72.2; 71.9; 51.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo (Other); 15% nano-HAP toothpaste (Device); 5% KNO3 toothpaste (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Cold Air Stimulus |
71.4; 72.2; 71.9; 51.1; 51.9; 62 | — |
| SECONDARY Measurement of Tactile Stimulus |
13.7; 14.1; 14.8; 23.6; 23.2; 17.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04590040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.