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

NCT ID: NCT04590040

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2023-03-01

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.

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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

5% KNO3 toothpaste

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

15% nano-HAP toothpaste

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0% nano-HAP toothpaste

Interventions

Placebo

0% nano-HAP toothpaste

Intervention Type: OTHER

15% nano-HAP toothpaste

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

Intervention Type: DEVICE

5% KNO3 toothpaste

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

Intervention Type: DEVICE

Other Intervention Names

Placebo toothpaste; 15 % nano-Hydroxyapatite toothpaste; 5% Potassium Nitrate Toothpaste

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sangi Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Bennett Amaechi

Professor and Director of Cariology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bennett T Amaechi, BDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health at San Antonio

Locations

School of Dentistry, University of Texas Health Science Center

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC20190535H

Identifier Type: -

Identifier Source: org_study_id