Dentin Sensitivity Clinical Trial
Official title:
Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Verified date | July 2023 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 192 |
Est. completion date | March 1, 2023 |
Est. primary completion date | February 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | School of Dentistry, University of Texas Health Science Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | Sangi Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of Cold Air Stimulus | The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (~70°F±3°F)(~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. | Week 0 (baseline), 4 weeks and 8 weeks | |
Secondary | Measurement of Tactile Stimulus | The secondary efficacy outcome will be the increase in tactile stimulus force from baseline to 8 weeks. Assessment of Change in tactile sensitivity will be assessed using the Yeaple Electronic Force Sensing Probe.The explorer tip will be applied perpendicular to the tooth surface and a pressure load applied starting at 10 g and increasing to 80g. The load at which the subject says "yes" will be recorded. (Baseline screening will begin at 30g). | Week 0 (baseline), 4 weeks and 8 weeks |
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