Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100, Italy
NCT Number: NCT04808180
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.
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Interventional
Not applicable
Pavia, Lombardy, 27100, Italy
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Teeth from this group will undergo the application of Biorepair Toothpaste for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
Teeth from this group will not be treated with the experimental toothpaste.
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria:
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria:
Time frame: Study begin, 1,2,3, 6 and 9 months
4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator.
The Index is calculated multiplying the total number of surfaces with plaque per 100.
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria:
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria:
Additionally, risk level for clinical management will be assessed.
University of Pavia
Other
Effects of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization: a Randomized Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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