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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

Tracking Information
First Submitted Date  ICMJE October 3, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date September 9, 2022
Actual Study Start Date  ICMJE July 28, 2020
Actual Primary Completion Date February 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • 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).
  • 4-week Cold Air stimulus [ Time Frame: Baseline and 4 weeks ]
    Change in cold air stimulus sensitivity from baseline to 4 weeks.
  • 4-week Tactile Stimulus [ Time Frame: Baseline and 4 weeks ]
    Change in tactile stimulus force from baseline to 4 weeks.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Official Title  ICMJE Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dentin Sensitivity
Intervention  ICMJE
  • Other: Placebo
    0% nano-HAP toothpaste
    Other Name: Placebo toothpaste
  • Device: 15% nano-HAP toothpaste
    Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
    Other Name: 15 % nano-Hydroxyapatite toothpaste
  • Device: 5% KNO3 toothpaste
    Toothpaste with identical base formulation as the placebo containing 5% KNO3
    Other Name: 5% Potassium Nitrate Toothpaste
Study Arms  ICMJE
  • 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.
    Intervention: Other: Placebo
  • 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.
    Intervention: Device: 15% nano-HAP 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.
    Intervention: Device: 5% KNO3 toothpaste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 8, 2022)
178
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE February 2023
Actual Primary Completion Date February 5, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04590040
Other Study ID Numbers  ICMJE HSC20190535H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be available at study completion
Current Responsible Party The University of Texas Health Science Center at San Antonio
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Sangi Co., Ltd.
Investigators  ICMJE
Principal Investigator: Bennett T Amaechi, BDS, MS, PhD University of Texas Health at San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP