Меню
Идёт набор NCT07158528

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

Без фазы С лечением Gingival Recession Generalized Moderate Gingival Recession Localized Moderate Gingival Recession, Generalized Gingival Recession, Localized

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 connective tissue graft, tunneled coronally advanced flap with a connective tissue graft.
Кому может быть актуально
Состояния в реестре: Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Gingival Recession, Generalized, Gingival Recession, Localized. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

An RCT Comparing Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With a Soft Tissue Graft for Multiple Recessions Coverage in the Maxilla.

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 relatively recently developed surgical approach. This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums at multiple adjacent teeth in the upper jaw. 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 connective tissue graft
    The gum at the recession site is elevated and repositioned 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 repositioned higher, combined with a connective tissue graft.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • At least 18 years of age
  • Good oral hygiene
  • Presence of multiple gingival recessions in the maxilla
  • Good general health

Критерии исключения

  • Smoker
  • Pregnant women (assessed at each visit; if the patient becomes pregnant during follow-up, radiographs 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: NCT07158528 · ONZ-2025-0158

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗