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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590040
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : September 9, 2022
Sponsor:
Collaborator:
Sangi Co., Ltd.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Other: Placebo Device: 15% nano-HAP toothpaste Device: 5% KNO3 toothpaste Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Actual Study Start Date : July 28, 2020
Actual Primary Completion Date : February 5, 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Durapatite

Arm Intervention/treatment
Placebo Comparator: Toothpaste 1
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 Name: Placebo 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 Name: 15 % nano-Hydroxyapatite toothpaste

Active Comparator: Toothpaste 3
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 Name: 5% Potassium Nitrate Toothpaste




Primary Outcome Measures :
  1. 8-week Cold Air Stimulus [ Time Frame: Baseline to 8 weeks ]
    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). The air will be directed perpendicular to the exposed root surface of the isolated sensitive tooth for one second from a distance of approximately one centimeter. Assessment of sensitivity will be carried out using Visual Analog Scale (VAS).


Secondary Outcome Measures :
  1. 8-week Tactile Stimulus [ Time Frame: Baseline and 8 weeks ]
    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).

  2. 4-week Cold Air stimulus [ Time Frame: Baseline and 4 weeks ]
    Change in cold air stimulus sensitivity from baseline to 4 weeks.

  3. 4-week Tactile Stimulus [ Time Frame: Baseline and 4 weeks ]
    Change in tactile stimulus force from baseline to 4 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590040


Locations
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United States, Texas
School of Dentistry, University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Sangi Co., Ltd.
Investigators
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Principal Investigator: Bennett T Amaechi, BDS, MS, PhD University of Texas Health at San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04590040    
Other Study ID Numbers: HSC20190535H
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared as de-identified data as summary results reported in ClinicalTrials.gov and in journal publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available at study completion

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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
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases