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Набор скоро начнётся NCT07329244

Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study

Без фазы С лечением Tooth Demineralization Tooth Sensitivity Enamel Mineralization Disorders Tooth Sensitivity After Composite Restorations

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Graphene-reinforced CAD/CAM polymer (G-CAM®).
Кому может быть актуально
Состояния в реестре: Tooth Demineralization, Tooth Sensitivity, Enamel Mineralization Disorders, Tooth Sensitivity After Composite Restorations. Базовые параметры: 10 лет — 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Evaluation of Graphene-Reinforced CAD/CAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study

Обзор

This study evaluates the clinical performance, marginal integrity, surface wear, color stability, and postoperative sensitivity of graphene-reinforced CAD/CAM indirect restorations (inlays, onlays, overlays) in molars affected by moderate to severe Molar-Incisor Hypomineralization (MIH) in adolescents. A total of 30 patients aged 10-16 years will receive minimally invasive indirect restorations fabricated from a nano-reinforced graphene polymer (G-CAM®). Clinical outcomes will be assessed using FDI criteria, VAS sensitivity scores, patient satisfaction, and digital 3D scans over a 12-month follow-up. The study aims to determine clinical acceptability and safety compared with historical outcomes reported for composite and lithium-disilicate indirect restorations.

Подробное описание

This is a prospective, single-arm, monocentric clinical trial designed to assess the functional performance, marginal adaptation, wear behavior, postoperative sensitivity, and structural preservation of graphene-reinforced CAD/CAM restorations placed on MIH-affected molars in adolescents aged 10-16 years. MIH lesions present compromised enamel quality with increased porosity, susceptibility to post-eruptive breakdown, and frequent hypersensitivity, making conventional restorative approaches less predictable.

Minimally invasive preparations will be performed followed by adhesive placement of graphene-reinforced CAD/CAM indirect restorations fabricated through a fully digital workflow (intraoral scanning, CAD design, CAM milling). Evaluations will be performed at baseline, 48 h, 1, 3, 6, and 12 months. Primary variables include global and domain-specific FDI clinical scores (marginal integrity, surface roughness, color stability, fractures/chipping, proximal contact, occlusion/function, soft tissue response) and postoperative sensitivity measured using a Visual Analog Scale (VAS). Secondary outcomes include patient satisfaction, tooth vitality, digital volumetric analysis of structural preservation, survival of restorations, and efficiency of the digital workflow.

Вмешательства

  • Устройство Graphene-reinforced CAD/CAM polymer (G-CAM®)
    Graphene-reinforced CAD/CAM polymer (G-CAM®) used for the fabrication of indirect inlay, onlay, or overlay restorations in permanent molars affected by molar-incisor hypomineralization (MIH). Restorations are fabricated using a digital CAD/CAM workflow and adhesively cemented under rubber dam isolation according to the study protocol.

Первичные конечные точки

  • Clinical Acceptability Assessed by the FDI World Dental Federation Clinical Criteria Score [Срок оценки: 12 months after restoration placement]
  • Postoperative Sensitivity Measured by Visual Analog Scale (VAS 0-10) [Срок оценки: Baseline (preoperative), 48 hours, 1 month, 3 months, 6 months, and 12 months]
Вторичные конечные точки (2)
  • Patient Satisfaction Measured by 5-Point Likert Scale [Срок оценки: 1 month, 3 months, 6 months, and 12 months]
  • Change in Tooth Structure Volume Measured by 3D Intraoral Scan Superimposition (mm³) [Срок оценки: Baseline and 12 months]

Критерии участия

Критерии включения

  • Adolescents aged 10-16 years.
  • Permanent molars with moderate or severe MIH (EAPD criteria).
  • Vital and restorable teeth.
  • Ability to attend follow-up visits.
  • Informed consent from guardian + assent from the minor.

Критерии исключения

  • Fluorosis, amelogenesis imperfecta, or other enamel defects.
  • Severe bruxism not controlled.
  • Active extensive caries or irreversible pulpitis.
  • Systemic conditions affecting enamel or healing.
  • Hypersensitivity/allergy to materials/adhesives.
  • Use of analgesics/AINEs <24 h before baseline VAS.
  • Orthodontic bands on the study molar.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Dental Esthetic BCN — Sarrià-Sant Gervasi

Публикации

  • Mendonca FL, Grizzo IC, Alencar CRB, Rios D. Restorative Therapy of MIH-Affected Molars. Monogr Oral Sci. 2024;32:236-260. doi: 10.1159/000538890. Epub 2024 Jul 1. PMID 39321762
  • Somani C, Taylor GD, Garot E, Rouas P, Lygidakis NA, Wong FSL. An update of treatment modalities in children and adolescents with teeth affected by molar incisor hypomineralisation (MIH): a systematic review. Eur Arch Paediatr Dent. 2022 Feb;23(1):39-64. doi: 10.1007/s40368-021-00635-0. Epub 2021 Jun 10. PMID 34110615

Идентификаторы

NCT: NCT07329244 · 64/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗