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N/A N=192 Randomized Double-blind Treatment

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

Dentin Sensitivity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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