Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients

Официальное название

Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients: Randomized Clinical Trial

Обзор

The aim of the following study is to evaluate the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. Patients who agree to participate to the study will use 2 different toothpaste Sensodyne Repair and Protect and Parodontax, which will used with split mouth design. The following indices will be measured: BEWE, Bleeding Index, Gingival Index, Plaque Index, Dental sensitivity test- Schiff, Pain Intensity Index- VAS and PPD.

Подробное описание

Informed consent will be signed by the parents of the patients underage and will be asked the approval for the attendance of the study. To the parents of pediatric patients will be given for free the 2 toothpastes and will be explain the correct procedures for home oral care. The method used in the study is "Split-Mouth" design, in which contralateral teeth with MIH will used for control group. For the study the patients must have at least two demineralizations present on contralateral permanent molars or incisors. The toothpaste used for the study consist in 2 different types: Sensodyne Repair\&Protect (used for the Trial group) and Parodontax Complete Protection (used for the control group).

The 2 toothpastes will be applied once a day, before going to sleep after normal oral hygiene, for at least two minutes for 28 days after each meeting. The products must be used in minimal quantities, in pea-size doses, applying it on the tooth with the finger while performing a massage, under the supervision of the parents and then rinsing.

At each meeting will be taken all the indices and the timing is: T0- study begin, T1- after 1 month, T2-after 3 months, T3- after 6 months, T4- after 9 months, T5- after 12 months.

Вмешательства

• Другое Novamin application
  Teeth from this group will be treated with the application of Sensodyne Repair\&Protect Toothpaste for 28 days after each visit (1 application per day for 2 minutes).
• Другое Parodontax application
  Teeth from this group will be treated with the application of Parodontax Complete Protection Toothpaste for 28 days after each visit (1 application per day for 2 minutes).

Первичные конечные точки

• Change in Bleeding Index [Срок оценки: Study begin, 1, 3, 6, 9, 12 months]
• Change in Gingival Index [Срок оценки: Study begin, 1, 3, 6, 9, 12 months]
• Change in Plaque Control Record [Срок оценки: Study begin, 1, 3, 6, 9, 12 months]
• Change in Schiff Air Index [Срок оценки: Study begin, 1, 3, 6, 9, 12 months]
• Change in Basic Erosive Wear Examination [Срок оценки: Study begin, 1, 3, 6, 9, 12 months]
• Change in Wong- Backer faces pain rating scales [Срок оценки: Study begin, 1, 3, 6, 9, 12 months]

Критерии участия

Критерии включения

• Presence of at least 2 demineralizations of the dental enamel of molars and incisors (molar incisor hypomineralization-MIH) on contralateral permanent teeth
• Patients with mild or moderate MIH
• Good general health (absence of particular systemic pathologies)

Критерии исключения

• Patients undergoing orthodontic therapy
• Patients taking drugs
• Patients with severe MIH (tooth surface with defect \> 2/3, post-eruptive enamel breakage)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Идентификаторы

NCT: NCT06396988 · 2024-MIHNOVAMIN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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