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Идёт набор NCT06940050

Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.

Без фазы С лечением Gingival Recession, Localized Gingival Recession, Plastic Surgery Gingival Recessions Gingival Recession, Mucogingival Surgery

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: Coronally advanced flap with a connective tissue graft, Tunneled coronally advanced flap with a connective tissue graft.
Кому может быть актуально
Состояния в реестре: Gingival Recession, Localized, Gingival Recession, Plastic Surgery, Gingival Recessions, Gingival Recession, Mucogingival Surgery. 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

An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.

Обзор

Multiple techniques can be used for recession coverage. The most common techniques are : tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a rather recent developed surgical approach. This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. The main question it aims to answer is: \- What is the average root coverage achieved with each technique in the short and long term? This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier. Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support. Participants will: * Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions * Attend regular check-ups for up to 10 years after surgery * Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)

Вмешательства

  • Процедура Coronally advanced flap with a connective tissue graft
    The gum at the recession site is detached and reattached higher (combined with a connective tissue graft).
  • Процедура Tunneled coronally advanced flap with a connective tissue graft
    The gum at the recession site is undermined, only partially detached and reattached higher (combined with a connective tissue graft).

Первичные конечные точки

  • mean root coverage [Срок оценки: From enrollment till ten years after surgical treatment.]
Вторичные конечные точки (12)
  • complete root coverage [Срок оценки: From enrollment till ten years after surgical treatment.]
  • pocket depth [Срок оценки: From enrollment till ten years after surgical treatment.]
  • recession reduction [Срок оценки: From enrollment till ten years after surgical treatment.]
  • width of keratinized tissue [Срок оценки: From enrollment till ten years after surgical treatment.]
  • gingival thickness [Срок оценки: From enrollment till ten years after surgical treatment.]
  • phenotype [Срок оценки: From enrollment till ten years after surgical treatment.]
  • treatment time [Срок оценки: Only measured during surgery in minutes.]
  • post-operative pain at donor site [Срок оценки: From one week post-operative till three months post-operative.]
  • post-operative pain at lower front [Срок оценки: From one week post-operative till three months post-operative.]
  • number of analgesics [Срок оценки: From one week post-operative till two weeks post-operative.]
  • score of aesthetic result [Срок оценки: From six months post-operative till ten years post-operative.]
  • root sensitivity [Срок оценки: From one week pre-operative till ten years post-operative.]

Критерии участия

Критерии включения

  • at least 18 years old
  • good oral hygiene
  • presence of at least 2 recessions in the premandible
  • good general health

Критерии исключения

  • smoker
  • pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)

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
  • Department of Periodontology and Implantology of Ghent University — Ghent

Идентификаторы

NCT: NCT06940050 · ONZ-2024-0498

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗