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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
Study Summary
This trial compares the effectiveness of two types of toothpaste in strengthening teeth.
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Mineral Density (MD) of Tooth
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
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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
452 Previous Clinical Trials
91,399 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken antibiotics in the last month.I need medication before any dental work due to a medical condition.I am willing to wear an intra-oral device all day.I am between 18 and 60 years old.I have severe gum disease.I have problems with my saliva production.I am taking medication that can change how much saliva I produce.I have a condition affecting my mouth's soft or hard tissues.I have at least 20 natural teeth, not counting wisdom teeth.My immune system is compromised due to a condition like HIV or medication.
Research Study Groups:
This trial has the following groups:- Group 1: MIH-bearing tooth block exposed to HAP toothpaste
- Group 2: MIH-bearing block exposed to Sodium Fluoride toothpaste
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are partaking in this experiment?
"Correct. Clinicaltrials.gov affirms that this medical trial, initially reported on September 6th 2022, is actively seeking participants. A total of 15 patients need to be recruited from one location."
Answered by AI
What criteria must be met for individuals to qualify for this research project?
"This trial is searching for 15 individuals aged 18 to 60 with molar incisor hypomineralization. Other conditions that must be met are: general health, no known allergies to products used in personal care and/or consumer goods, a minimum of 20 natural teeth (exclude 3rd molars), regular salivary flow rate, ability to consent, availability throughout the entire course of study, willingness to wear intra-oral appliance daily and agreement on using only assigned oral hygiene products until completion."
Answered by AI
Is the upper age limit set for those participating in this research?
"This medical trial seeks participants who are over 18 and under the age of 60."
Answered by AI
Are participants still being accepted for this research project?
"Absolutely. According to the information present on clinicaltrials.gov, this study is currently recruiting participants. First posted on September 6th 2022 and later amended November 4th 2022, 15 subjects need to be enrolled at a single locale for this trial to commence."
Answered by AI
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