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Идёт набор NCT07513792

The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With Aligners

Без фазы С лечением Orthodontic Gingival Recession Cone-Beam Computed Tomography

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: 3D CBCT-Guided Orthodontic Treatment with Aligners, conventional orthodontic treatment planning.
Кому может быть актуально
Состояния в реестре: Orthodontic, Gingival Recession, Cone-Beam Computed Tomography. Базовые параметры: от 18 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
Бельгия
Следующий шаг
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Официальное название

The Impact of a 3D Imaging Visualization Tool for Orthodontic Treatment With Aligners in Reducing Periodontal Recession Occurrence

Обзор

This study investigates whether using 3D imaging technology (Cone Beam Computed Tomography or CBCT) for orthodontic treatment planning with aligners can reduce the risk of gingival recession in adult patients seeking dental arch expansion. Many aligner treatments involve expanding the dental arches to address issues like crowding and "black corridors," but this can sometimes lead to gum recession. The research compares two groups of patients: one group will have their treatment planned using CBCT, which allows for detailed 3D visualization of the teeth and bone structure, while the other group will follow a conventional 2D treatment plan. The goal is to see if the 3D tool helps prevent gum recession and other periodontal problems like bone thinning, as well as to assess the impact on other factors like upper airway dimensions. The study is a randomized controlled trial with 40 participants. It will track changes in gum health, bone structure, and airway volume over the course of treatment. The researchers aim to find out if the advanced imaging tool provides significant benefits compared to traditional planning methods.

Вмешательства

  • Устройство 3D CBCT-Guided Orthodontic Treatment with Aligners
    This intervention involves orthodontic treatment with clear aligners, where the treatment planning is guided by Cone Beam Computed Tomography (CBCT). The CBCT data is integrated into the digital planning software to allow 3D visualization of teeth and surrounding bone structures. This enables precise planning of tooth movements within the bony envelope, aiming to reduce the risk of gingival recession and other periodontal complications associated with arch expansion.
  • Устройство conventional orthodontic treatment planning
    Orthodontic treatment planning is traditionally based on two-dimensional radiographs (cephalometric and panoramic), which do not provide information about the three-dimensional position of teeth and their roots within the alveolar bone.

Первичные конечные точки

  • Change in total gingival recession severity score (S1 - S0) [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
Вторичные конечные точки (7)
  • Change in buccal bone dehiscence [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
  • Change in keratinized tissue height [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
  • Change in buccal bone thickness (mm) [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
  • Presence of bone fenestration [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
  • Change in upper airway volume [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
  • Change in smallest transverse upper airway dimension [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]
  • Change in Epworth Sleepiness Scale score [Срок оценки: Baseline and at completion of treatment (approximately 12 months)]

Критерии участия

Критерии включения

  • more than 18years old
  • requesting an orthodontic treatment with aligners
  • dental class I or slight class II or III
  • presence of black corridors

Критерии исключения

  • agenesis or extraction except for the 3rd molars
  • need of extraction for the orthodontic treatment-need for orthognathic surgery
  • generalized unilateral, bilateral, or anterior crossbite
  • active periodontal disease
  • presence of severe recession (≥2mm)
  • furcation involvement
  • absence of keratinized tissues
  • smoker > 10c/day-auto-immune disease or immunocompromised patients
  • uncontrolled diabetes
  • use of steroids or biphosphonates-local or systemic infection (medical treatment needed prior to entrance to the study)
  • pregnancy
  • alcoholism or chronically drug abuse

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • University of Liege — Liège

Идентификаторы

NCT: NCT07513792 · 2023/109

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗