Effect of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel on the MIH-affected Permanent Teeth

Официальное название

Comparative Evaluation of Three Different Topically Applied Materials as Non-invasive Treatment of Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial

Обзор

This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing MIH-affected teeth.

Подробное описание

This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene, and gingival health, oral health-related quality of life, preventing post-eruptive enamel breakdown, and dental caries, along with economic evaluation.

Вмешательства

• Препарат nano hydroxy apatite varnish
  Intervention (1)
• Препарат Potassium Nitrate Gel
  Intervention (2)
• Препарат Varnishes, Fluoride
  Control

Первичные конечные точки

• Dentin Hypersensitivity [Срок оценки: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.]
• Dentin Hypersensitivity [Срок оценки: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.]

Вторичные конечные точки (5)

• Post-eruptive enamel breakdown [Срок оценки: : baseline, 3-, 6-, 9-, and 12- month post-op.]
• Caries incidence [Срок оценки: baseline, 3-, 6-, 9-, and 12- month post-op.]
• Oral hygiene [Срок оценки: baseline, 2-, and 4- week post-op.]
• Oral health-related quality of life [Срок оценки: baseline, 6-, and 12- month post-op.]
• Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER [Срок оценки: 12-month- post-op.]

Критерии участия

The research unit of this study will be the MIH-affected permanent tooth, in children aged from six to ten years, from either gender.

Критерии включения

Participants related criteria:

• Children aged from six to ten years old.
• Medically free children according to the history taken from their parents.
• Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA).
• Children whom their parents accept to comply with the follow-up visits.
• Children who accept, and their guardians, to participate in the study by signing the informed consent.
• Children with no more than four cavitated primary teeth.

Tooth related criteria:

1\. The diagnosis of MIH will be done as per the Wurzburg concept, 2023 MIH diagnostic criteria:

The child will be confirmed to have MIH if any of the following characteristics are apparent:

• affected teeth show a clearly defined opacity at the occlusal and buccal surfaces of a tooth,
• defects vary in shape, size, and pattern,
• white, cream-colored, or yellow-brown color deviations are recognizable,
• defects variably vary in size,
• teeth with hypersensitivity are present,
• teeth have an atypical restoration,
• permanent teeth for (suspected) MIH reasons are missing (extractions),
• combinations of the above characteristics are present.

• MIH-affected permanent teeth, suffering from dentin hypersensitivity, (MIH-TNI 3, 4a).
• Positive Schiff Cold Airblasting Sensitivity score (score 1, 2, or 3).

• Exclusion criteria:

Participants related criteria:

• Children with severe behavioral or emotional disabilities.
• Children who received analgesics within the last 24 hours before the procedure.15
• Patients who are using chlorhexidine-based gels or mouthwashes.

Tooth related criteria:

• A tooth with signs and symptoms of irreversible pulpitis.
• A tooth with signs and symptoms of necrotic pulp.
• Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study.
• Presence of dental caries on the MIH-affected permanent tooth.
• Presence of restoration(s) on MIH-affected permanent tooth.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06896565 · 22222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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