Меню
Идёт набор NCT07158541

Comparing TCAF and MTUN With Soft Tissue Grafting for Treating Single Recessions in the Premandible

Без фазы С лечением Gingival Recession, Localized Gingival Recession Localized Moderate Gingival Recession 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: tunneled coronally advanced flap with connective tissue graft, modified tunnel with connective tissue graft.
Кому может быть актуально
Состояния в реестре: Gingival Recession, Localized, Gingival Recession Localized Moderate, Gingival Recession, 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
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 Tunneled Coronally Advanced Flap (TCAF) and Modified Tunnel Technique (MTUN) in Combination With a Soft Tissue Graft for Single Recession Coverage

Обзор

Multiple techniques can be used for recession coverage. The most common techniques for single recessions are : tunnel technique (T) and coronally advanced flap (CAF) both combined with a palatal graft to provide sufficient gingival thickness. Recently two modifications have been described in literature, namely the tunneled coronally advanced flap and the modified tunnel. MTUN will function as the control group while people treated with the TCAF technique will function as the test group. This randomized controlled trial compares MTUN and TCAF to determine which technique provides better root coverage for receding gums at single recession in the premandible. 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 modified tunnel technique (MTUN = the gum is undermined) 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. Pain associated to the material used to cover the donorsite will be seen as the secondary research question. The site will either be covered by spongostan and multiple stitches or a palatal stent. Participants will: * Undergo surgery (MTUN 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 tunneled coronally advanced flap with connective tissue graft
    The gum at the recession site is undermined, only partially detached and reattached higher (combined withh a connective tissue graft).
  • Процедура modified tunnel with connective tissue graft
    At the recession site, the gingiva is undermined to create a tunnel, and a connective tissue graft is inserted through the sulcus into this space before advancing the flap coronally.

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 aesthetic result [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 old
  • good oral hygiene
  • presence of one recession 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: NCT07158541 · ONZ-2025-0160

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗