Assessment of Hard and Soft Tissue Changes Following XCM Versus FGG Simultaneous With Delayed Dental Implant Placement

Официальное название

Assessment of Hard and Soft Tissue Changes Following Xenogeneic Collagen Membrane Versus Free Gingival Graft Simultaneous With Delayed Dental Implant Placement: Randomized Controlled Clinical Trial

Обзор

Teeth loss are usually associated with alterations of extraction sockets result in obviously absorbed alveolar ridges and are often accompanied with soft tissue atrophy such as narrow keratinized tissue and a shallow vestibule. Lack of peri-implant keratinized tissue is a potential risk to peri-implant diseases. Although the role of width of KM in maintaining peri-implant health is a controversial topic, the majority of high-level evidence has suggested that a minimum KM width (KMW) of 2 mm around the dental implants is critical to maintain peri-implant health and the long-term survival of dental implants.

Подробное описание

This study will be carried out on patients attending outpatient clinic of Oral maxillofacial surgery and Periodontology Departments, Faculty of Dentistry. Modern University for Technology and Information, Cairo, Egypt.

P: Healthy patients with posterior missing teeth with deficient keratinized tissue to receive delayed dental implant placement I: Xenogeneic collagen membrane (XCM) simultaneous with delayed implant placement C: Free gingival graft (FGG) simultaneous with delayed implant placement O: Keratinized tissue width (KMW), graft shrinkage (GS), marginal bone loss (MBL) T- One year S- Randomized controlled clinical trial.

Eligible patients will be divided into equal proportions between control group and test group.

The control group "Group 1" will receive FGG simultaneous with implant placement The test group "Group 2" will receive XCM simultaneous with implant placement

Вмешательства

• Процедура Free gingival graft simultaneous with delayed implant placement
  XCM grafts (of bovine origin)
• Процедура Xenogeneic collagen matrix simultaneous with delayed implant placement
  A FGG will be harvested from the palate between first premolar and first molar

Первичные конечные точки

• Keratinized tissue width [Срок оценки: One year]
• graft shrinkage [Срок оценки: One year]
• marginal bone loss [Срок оценки: One year]

Критерии участия

Критерии включения

• Adults above the age of 18 years.
• Presence of 2mm or less of keratinized tissue width
• Sufficient alveolar ridge width minimum of 6 mm
• Patients with good oral hygiene as evidenced by plaque index (PI)<1 and showing cooperation or compliance with treatment.

Критерии исключения

• Patients diagnosed with periodontal diseases (Caton et al., 2018).
• Acute active infection at implant sites
• Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous bisphosphonates for treatment of osteoporosis and radiotherapy
• Patients with parafunctional habits.
• Smokers (≥10 cigarettes per day),

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• MTI University — Cairo

Идентификаторы

NCT: NCT07080177 · MTI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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