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

Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study

This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Other: Hydroxyapatite toothpaste; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • School of Dentistry, University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MIH-bearing tooth block exposed to HAP toothpaste; A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste	Other: Hydroxyapatite toothpaste; 10% Hydroxyapatite toothpaste; Other Names: HAP toothpaste
Other: MIH-bearing block exposed to Sodium Fluoride 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	Other: Sodium Fluoride Toothpaste; 1450 parts per million sodium fluoride toothpaste; Other Names: NaF toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mineral Density (MD) of Tooth	Images will be collected from the samples to measure the mineral density before and after remineralization treatment. Total number of subjects enrolled in either the first allocation or the second allocation after the washout are included.	Baseline to 2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Dr. Kurt Wolff GmbH & Co. KG
• Investigators: Principal Investigator: Bennett T Amaechi, BDS, MS, PhD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hydroxyapatite; Remineralization; Sodium fluoride
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Dental Enamel Hypoplasia; Molar Hypomineralization; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: HSC20210570H

Drug and device information, study documents

• 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