Purpose

This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
This is a double-blind, randomized, sequential, single center, controlled clinical trial.
Primary Purpose
Other
Masking
Double (Participant, Investigator)
Masking Description
The study will be blinded to both the study team and the subjects.

Arm Groups

ArmDescriptionAssigned Intervention
Other
MIH-bearing tooth block exposed to HAP toothpaste
A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste
  • Other: Hydroxyapatite toothpaste
    10% Hydroxyapatite toothpaste
    Other names:
    • HAP toothpaste
Other
MIH-bearing block exposed to Sodium Fluoride toothpaste
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
  • Other: Sodium Fluoride Toothpaste
    1450 parts per million sodium fluoride toothpaste
    Other names:
    • NaF toothpaste

Recruiting Locations

School of Dentistry, University of Texas Health Science Center
San Antonio, Texas 78229
Contact:
Bennett T Amaechi, BDS, MS, PhD
210-567-3185
amaechi@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Bennett T Amaechi, BDS, MS, PhD
210 834 7675
Amaechi@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.