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

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485662
• Other study ID #: HSC20210570H
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Other:
• Hydroxyapatite toothpaste
10% Hydroxyapatite toothpaste
• Sodium Fluoride Toothpaste
1450 parts per million sodium fluoride toothpaste

Locations

Country	Name	City	State
United States	School of Dentistry, University of Texas Health Science Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Dr. Kurt Wolff GmbH & Co. KG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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