Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05485662
Other study ID # HSC20210570H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2022
Est. completion date December 9, 2022

Study information

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

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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)

Study Design


Intervention

Other:
Hydroxyapatite toothpaste
10% Hydroxyapatite toothpaste
Sodium Fluoride Toothpaste
1450 parts per million sodium fluoride toothpaste

Locations

Country Name City State
United States School of Dentistry, University of Texas Health Science Center San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio Dr. Kurt Wolff GmbH & Co. KG

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06342089 - Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus.
Not yet recruiting NCT06081491 - Association Between Molar-Incisor Hypomineralization, Maternal Stress and Anxiety: A Cross-Sectional Study.
Not yet recruiting NCT04410172 - Prevalence of MIH Among Group of Egyptians Children Aged From 8 to 12 in Damietta
Not yet recruiting NCT04030936 - Knowledge Regarding Diagnosis of MIH Among Dental Interns in Faculty of Dentistry Cairo University
Not yet recruiting NCT04420520 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools
Active, not recruiting NCT05597956 - Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities N/A
Completed NCT04231019 - Knowledge of Egyptian Dental Practitioners Regarding Molar-Incisor Hypomineralization
Completed NCT03735069 - Vital Pulp Therapy in Carious Teeth With Hypomineralization N/A
Completed NCT05494749 - Zirconia Reinforced Glass Ionomer in MIH N/A
Not yet recruiting NCT04475419 - Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization N/A
Completed NCT05931822 - Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar. N/A
Completed NCT04061096 - Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization N/A
Active, not recruiting NCT05748067 - Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects N/A
Not yet recruiting NCT03583671 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children From 8 to 12 Years Old in Dakahlia
Active, not recruiting NCT03870958 - Glass Ionomer Cement Sealant in the Prevention of Post-eruptive Fractures in Molars Affected by MIH N/A
Completed NCT05727475 - Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH N/A
Completed NCT04685889 - Resin Infiltration Treatment for MIH N/A
Not yet recruiting NCT06330272 - Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study N/A
Enrolling by invitation NCT03233464 - Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate N/A
Completed NCT04103710 - Prevalence of Molar Incisor Hypomineralization Among Children Treated With Asthmatic Drugs Early in Their Lives