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Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste

Primary Purpose

Molar Incisor Hypomineralization

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydroxyapatite toothpaste
Sodium Fluoride 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 other trial for Molar Incisor Hypomineralization focused on measuring Remineralization, Hydroxyapatite, Sodium fluoride

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-60 years of age
  • Good general health
  • No known history of allergy to personal care/consumer products
  • Minimum of 20 natural uncrowned teeth (excluding third molars)
  • Normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively
  • Able to consent
  • Availability throughout entire study
  • Willing to wear intra-oral appliance 24 hours per day
  • Willing to use only assigned products for oral hygiene for duration of study

Exclusion Criteria:

  • Advanced periodontal disease
  • A medical condition that requires pre-medication prior to dental visits/procedures
  • Impaired salivary function
  • Orthodontic retainer(s)
  • Too few teeth to secure the oral appliance
  • Disease of the soft or hard oral tissues
  • Use of drugs that can affect salivary flow
  • Use of antibiotics one month prior to or during this study
  • Participation in another clinical study one week prior to the start of washout period or during this study period
  • Allergic hisotry to common toothpaste ingredients
  • Compromised immune system (HIV, AIDS, Immunosuppressive drug therapy)

Sites / Locations

  • School of Dentistry, University of Texas Health Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

MIH-bearing tooth block exposed to HAP toothpaste

MIH-bearing block exposed to Sodium Fluoride toothpaste

Arm Description

A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste

A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste

Outcomes

Primary Outcome Measures

Change in mineral density (MD) of tooth
Images will be collected from the samples to measure the mineral density before and after remineralization treatment.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2022
Last Updated
November 4, 2022
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Dr. Kurt Wolff GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT05485662
Brief Title
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste
Official Title
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Dr. Kurt Wolff GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.
Detailed Description
Prior to each 2-week treatment phase, subjects will complete a 1-week washout period. Following the washout period, the intra-oral appliance containing a donorMIH tooth block will be fitted to each subject by a qualified dentist. Immediately after fitting of the first appliance (on day 1 of the first treatment phase), each subject will receive a soft bristled manual toothbrush for use throughout the duration of the study and a toothpaste according to the treatment phase. Subjects will be instructed to brush their teeth with the appliance in the mouth, two times daily, for 3 minutes on each brushing episode, in the morning after breakfast and last thing before bed, then rinsing with 10 ml of water. Over the study period, all subjects will maintain their normal dietary habits. A 7-day washout period without an appliance will follow. After completion of the second washout period, subjects will return to the clinic, and the appliance, with another MIH-bearing tooth blocks mounted, will be fitted to the subject for the phase 2 treatment period. This procedure will then be repeated until the 2-week treatment phase is completed, and each subject has gone through the two arms of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
Keywords
Remineralization, Hydroxyapatite, Sodium fluoride

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This is a double-blind, randomized, sequential, single center, controlled clinical trial.
Masking
ParticipantInvestigator
Masking Description
The study will be blinded to both the study team and the subjects.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIH-bearing tooth block exposed to HAP toothpaste
Arm Type
Other
Arm Description
A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste
Arm Title
MIH-bearing block exposed to Sodium Fluoride toothpaste
Arm Type
Other
Arm Description
A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste
Intervention Type
Other
Intervention Name(s)
Hydroxyapatite toothpaste
Other Intervention Name(s)
HAP toothpaste
Intervention Description
10% Hydroxyapatite toothpaste
Intervention Type
Other
Intervention Name(s)
Sodium Fluoride Toothpaste
Other Intervention Name(s)
NaF toothpaste
Intervention Description
1450 parts per million sodium fluoride toothpaste
Primary Outcome Measure Information:
Title
Change in mineral density (MD) of tooth
Description
Images will be collected from the samples to measure the mineral density before and after remineralization treatment.
Time Frame
Baseline to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-60 years of age Good general health No known history of allergy to personal care/consumer products Minimum of 20 natural uncrowned teeth (excluding third molars) Normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively Able to consent Availability throughout entire study Willing to wear intra-oral appliance 24 hours per day Willing to use only assigned products for oral hygiene for duration of study Exclusion Criteria: Advanced periodontal disease A medical condition that requires pre-medication prior to dental visits/procedures Impaired salivary function Orthodontic retainer(s) Too few teeth to secure the oral appliance Disease of the soft or hard oral tissues Use of drugs that can affect salivary flow Use of antibiotics one month prior to or during this study Participation in another clinical study one week prior to the start of washout period or during this study period Allergic hisotry to common toothpaste ingredients Compromised immune system (HIV, AIDS, Immunosuppressive drug therapy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bennett T Amaechi, BDS, MS, PhD
Phone
210 834 7675
Email
Amaechi@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS, MS, PhD
Organizational Affiliation
University of Texas Health Science Center 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS, MS, PhD
Phone
210-567-3185
Email
amaechi@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS, MS, PhD

12. IPD Sharing Statement

Learn more about this trial

Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste

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