Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar

Status Completed

Clinical Trial Summary

The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.

Clinical Trial Description

Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study. Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study. Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray. Teeth will be randomly assigned to: - Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes). - Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04808180
Study type	Interventional
Source	University of Pavia
Contact
Status	Completed
Phase	N/A
Start date	March 25, 2021
Completion date	February 1, 2022

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See also
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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
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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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms