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

Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity

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.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Other: Placebo; Device: 15% nano-HAP toothpaste; Device: 5% KNO3 toothpaste

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • School of Dentistry, University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Toothpaste 1; 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.	Device: 5% KNO3 toothpaste; Toothpaste with identical base formulation as the placebo containing 5% KNO3; Other Names: 5% Potassium Nitrate Toothpaste
Active Comparator: Toothpaste 2; 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.	Device: 15% nano-HAP toothpaste; Toothpaste with identical base formulation as the placebo containing 15% nano-HAP; Other Names: 15 % nano-Hydroxyapatite toothpaste
Placebo Comparator: Toothpaste 3; 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.	Other: Placebo; 0% nano-HAP toothpaste; Other Names: Placebo toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Sangi Co., Ltd.
• Investigators: Principal Investigator: Bennett T Amaechi, BDS, MS, PhD, University of Texas Health at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): February 5, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: October 3, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: HSC20190535H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared as de-identified data as summary results reported in ClinicalTrials.gov and in journal publication.
• IPD Sharing Time Frame: Data will be available at study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No