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Toothpaste

Hydroxyapatite Toothpaste for Molar Incisor Hypomineralization

N/A
Waitlist Available
Led By Bennett T Amaechi, BDS, MS, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests two types of toothpaste to see which one better repairs damaged teeth. Participants will use either a mineral-adding toothpaste or a decay-resistant toothpaste. The mineral-adding toothpaste helps by adding minerals back into the teeth, while the decay-resistant toothpaste makes the teeth more resistant to decay. The mineral-adding toothpaste has been studied for its potential to prevent root damage and reduce tooth sensitivity.

Who is the study for?
This trial is for adults aged 18-60 with good general health, normal saliva flow, and at least 20 natural teeth. They must be willing to use only the assigned toothpaste for oral hygiene during the study and wear an intra-oral appliance all day. People with orthodontic retainers, impaired salivary function, recent antibiotic use or participation in other clinical studies are excluded.
What is being tested?
The study compares two types of toothpaste: one with hydroxyapatite (HAP) and another with sodium fluoride. It aims to see which better remineralizes teeth affected by Molar Incisor Hypomineralization (MIH). Participants will use these products on donor teeth placed in an oral appliance.
What are the potential side effects?
There may not be significant side effects as both hydroxyapatite and sodium fluoride toothpastes are generally considered safe for dental use. However, some individuals might experience mild irritation or allergic reactions if they have sensitivities to specific ingredients in the toothpaste.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mineral Density (MD) of Tooth

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MIH-bearing tooth block exposed to HAP toothpasteExperimental Treatment1 Intervention
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 II: MIH-bearing block exposed to Sodium Fluoride toothpasteExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Dr. Kurt Wolff GmbH & Co. KGIndustry Sponsor
2 Previous Clinical Trials
392 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
475 Previous Clinical Trials
92,301 Total Patients Enrolled
Bennett T Amaechi, BDS, MS, PhDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
4 Previous Clinical Trials
573 Total Patients Enrolled

Media Library

Hydroxyapatite Toothpaste (Toothpaste) Clinical Trial Eligibility Overview. Trial Name: NCT05485662 — N/A
Molar Incisor Hypomineralization Research Study Groups: MIH-bearing tooth block exposed to HAP toothpaste, MIH-bearing block exposed to Sodium Fluoride toothpaste
Molar Incisor Hypomineralization Clinical Trial 2023: Hydroxyapatite Toothpaste Highlights & Side Effects. Trial Name: NCT05485662 — N/A
Hydroxyapatite Toothpaste (Toothpaste) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05485662 — N/A
~5 spots leftby Nov 2025