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

NCT05485662 | Completed Results

• 1 other identifier: HSC20210570H
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Molar Incisor Hypomineralization

Keywords

Remineralization; Hydroxyapatite; Sodium fluoride

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MIH-bearing tooth block exposed to HAP toothpaste

OTHER

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

MIH-bearing block exposed to Sodium Fluoride toothpaste

OTHER

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

Interventions

Hydroxyapatite toothpaste OTHER

10% Hydroxyapatite toothpaste

Also known as: HAP toothpaste

MIH-bearing tooth block exposed to HAP toothpaste

Sodium Fluoride Toothpaste OTHER

1450 parts per million sodium fluoride toothpaste

Also known as: NaF toothpaste

MIH-bearing block exposed to Sodium Fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Dr. Kurt Wolff GmbH & Co. KG: collaborator

Study Sites (1)

School of Dentistry, University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Bennett Amaechi, BDS, MD, PhD
• Organization: UT Health San Antonio

amaechi@uthscsa.edu

210 567 3185

Study Officials

• Bennett T Amaechi, BDS, MS, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be blinded to both the study team and the subjects.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, randomized, sequential, single center, controlled clinical trial.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: September 6, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: April 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2024-04

Locations

US (1)