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

NCT04590040 | Completed Results FDA Device

• 1 other identifier: HSC20190535H
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of Tactile Stimulus

  Week 0 (baseline), 4 weeks and 8 weeks

Study Arms (3)

Toothpaste 1

ACTIVE COMPARATOR

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 2

ACTIVE COMPARATOR

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 3

PLACEBO COMPARATOR

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

Interventions

Placebo OTHER

0% nano-HAP toothpaste

Also known as: Placebo toothpaste

Toothpaste 3

15% nano-HAP toothpaste DEVICE

Toothpaste with identical base formulation as the placebo containing 15% nano-HAP

Also known as: 15 % nano-Hydroxyapatite toothpaste

Toothpaste 2

5% KNO3 toothpaste DEVICE

Toothpaste with identical base formulation as the placebo containing 5% KNO3

Also known as: 5% Potassium Nitrate Toothpaste

Toothpaste 1

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Sangi Co., Ltd.: collaborator

Study Sites (1)

School of Dentistry, University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Bennett Amaechi BDS, MD, PhD
• Organization: UT Health San Antonio

amaechi@uthscsa.edu

210 567 3185

Study Officials

• Bennett T Amaechi, BDS, MS, PhD

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Cariology

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 19, 2020
• Study Start: July 28, 2020
• Primary Completion: February 5, 2022
• Study Completion: March 1, 2023
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at study completion

Locations

US (1)