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

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
15% nano-HAP toothpaste
5% KNO3 toothpaste
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry, University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Toothpaste 1

Toothpaste 2

Toothpaste 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
October 3, 2020
Last Updated
July 24, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Sangi Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04590040
Brief Title
Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Official Title
Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
February 5, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Sangi Co., Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toothpaste 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Toothpaste 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Toothpaste 3
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo toothpaste
Intervention Description
0% nano-HAP toothpaste
Intervention Type
Device
Intervention Name(s)
15% nano-HAP toothpaste
Other Intervention Name(s)
15 % nano-Hydroxyapatite toothpaste
Intervention Description
Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
Intervention Type
Device
Intervention Name(s)
5% KNO3 toothpaste
Other Intervention Name(s)
5% Potassium Nitrate Toothpaste
Intervention Description
Toothpaste with identical base formulation as the placebo containing 5% KNO3
Primary Outcome Measure Information:
Title
Measurement of Cold Air Stimulus
Description
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.
Time Frame
Week 0 (baseline), 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Measurement of Tactile Stimulus
Description
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).
Time Frame
Week 0 (baseline), 4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS, MS, PhD
Organizational Affiliation
University of Texas Health at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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