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Идёт набор NCT07453147

Selective Versus Contiguous Connective Tissue Grafts in the Modified Tunnel Technique

Без фазы С лечением Gum Recession

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: Selective/Segmented graft, Continuous graft.
Кому может быть актуально
Состояния в реестре: Gum Recession. 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, Франция
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

Evaluation of the Modified Coronally Advanced Tunnel Technique Associated With a Selective/Segmented Versus Contiguous Submerged Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: Randomised Controlled Clinical Trial

Обзор

The goal of this study is to evaluate how effective a gum grafting procedure is in treating gum recession that affects several teeth. Gum recession happens when the gum tissue pulls away from the tooth, exposing the roots. The study will look at how the treatment improves gum health, appearance, and function. A total of 32 patients will take part in the study. All patients will be treated with a modified coronally advanced tunnel. For half of them of contiguous graft will be used, for the other half a segmented graft. Data collected will include medical history, dental and aesthetic information, clinical measurements, and a digital scan of the mouth. The study will include the following steps: Before the procedure: You will have a clinical and X-ray examination to determine how much your gums have receded. A digital impression of your teeth will also be taken. Surgical procedure: You will receive a gum graft to cover the exposed roots. This involves moving gum tissue, often taken from the roof of your mouth, to the affected areas. After the procedure: You will have several follow-up visits over a few months to check your healing and the results of the treatment. Study timeline: The surgery will be done once. Follow-up visits will take place 1, 3, 6, and 12 months after the surgery. The total duration of the study is about 12 months.

Вмешательства

  • Процедура Selective/Segmented graft
    In this group a segmented CTG will be used
  • Процедура Continuous graft
    In this group a continuous CTG will be used

Первичные конечные точки

  • Digital complete root coverage [Срок оценки: 3, 6 and 12 months]
Вторичные конечные точки (11)
  • Complete Root Coverage [Срок оценки: 3, 6 and 12 months]
  • Mean Root Coverage [Срок оценки: 3, 6 and 12 months]
  • Keratinized Tissue Height [Срок оценки: 3, 6 and 12 months]
  • Recession reduction [Срок оценки: 3, 6 and 12 months]
  • Dental hypersensitivity [Срок оценки: 3, 6 and 12 months]
  • Root-coverage Esthetic Score [Срок оценки: 3, 6 and 12 months]
  • Digital mean root coverage [Срок оценки: 3, 6 and 12 months]
  • Digital recession reduction [Срок оценки: 3, 6 and 12 months]
  • Digital Gingival soft tissues profile [Срок оценки: 3, 6 and 12 months]
  • Volumetric Changes [Срок оценки: 3, 6 and 12 months]
  • Patient Reported Outcome Measures [Срок оценки: 1, 2, 3, 4, 5, 6, 7, 14 days and 3, 6, 12 months]

Критерии участия

Критерии включения

  • ASA I or ASA II
  • Good periodontal health
  • Able to undergo oral surgery
  • Must be 18 years old and older
  • No smoking
  • At least two teeth in the same sector in the maxilla and the right and left mandible (except in the mandibular incisive sector), of which at least 2 are contiguous, with vestibular gingival recessions of type RT 1 of 1-5mm (Cairo et al. 2011)
  • An identifiable or restorable cemento-enamel junction (CEJ), with or without the presence of a non-carious cervical lesion (Pini-Prato et al. 2010)
  • Plaque index (O'Leary 1972) and bleeding index (Ainamo et al. 1975) scores of less than 20%
  • Able to give informed consent and have signed the consent forms

Критерии исключения

  • Teeth showing recession associated with a carious lesion, restoration or cervical prosthesis involving CEJ
  • Teeth with recession depth >5mm
  • Molars with recessions will be treated but will not be taken into account for the measurements
  • Teeth with recession that have already undergone periodontal surgery
  • Presence of severe tooth malposition, rotation or significant version of the tooth
  • Smoker and ex-smoker
  • Patient suffering from a disease affecting the periodontium
  • Patient with clinical signs of active periodontitis
  • Known pregnancy in progress or breastfeeding
  • Contraindication to surgery
  • Conditions or circumstances which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
  • Patients deprived of their liberty or under legal protection

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • CHU de Liège — Liège
Франция · 1 центр
  • 26K Center for clinical research — Paris

Идентификаторы

NCT: NCT07453147 · B7072025000052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗