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

NCT ID: NCT05485662

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2022-12-09

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.

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: OTHER

Hydroxyapatite toothpaste

Intervention Type: OTHER

10% Hydroxyapatite toothpaste

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

Group Type: OTHER

Sodium Fluoride Toothpaste

Intervention Type: OTHER

1450 parts per million sodium fluoride toothpaste

Interventions

Hydroxyapatite toothpaste

10% Hydroxyapatite toothpaste

Intervention Type: OTHER

Sodium Fluoride Toothpaste

1450 parts per million sodium fluoride toothpaste

Intervention Type: OTHER

Other Intervention Names

HAP toothpaste; NaF toothpaste

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Kurt Wolff GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bennett T Amaechi, BDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

School of Dentistry, University of Texas Health Science Center

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC20210570H

Identifier Type: -

Identifier Source: org_study_id