N/A
N=15
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste
Molar Incisor Hypomineralization
Bottom Line
View on ClinicalTrials.gov: NCT05485662 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Change in Mineral Density (MD) of Tooth — 26.02; 14.64; 29.26; 16.83 percentage of remineralization
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydroxyapatite toothpaste (Other); Sodium Fluoride Toothpaste (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mineral Density (MD) of Tooth |
26.02; 14.64; 29.26; 16.83; 16.62; 10.62 | — |
Summary
This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05485662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.