NCT05485662

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Hydroxyapatite toothpaste	10% Hydroxyapatite toothpaste
OTHER	Sodium Fluoride Toothpaste	1450 parts per million sodium fluoride toothpaste

Timeline

• Start date: 2022-09-06
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2022-08-03
• Last updated: 2024-04-12
• Results posted: 2024-01-12

Locations

1 site across 1 country: United States