Molar Incisor Hypomineralization Clinical Trial
Official title:
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study
Verified date | April 2024 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.
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) |
Country | Name | City | State |
---|---|---|---|
United States | School of Dentistry, University of Texas Health Science Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | Dr. Kurt Wolff GmbH & Co. KG |
United States,
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 |
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