Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets

Официальное название

Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets: A Randomized Controlled Clinical Trial

Обзор

This randomized controlled clinical trial evaluates the effectiveness of bioresorbable magnesium membranes compared to traditional cortical lamina in Vestibular Socket Therapy (VST) for immediate implant placement in Type II extraction sockets. The study utilizes Vestibular Socket Therapy (VST), a minimally invasive technique that involves a small incision and a subperiosteal tunnel to place a "bone shield" and graft without the need to raise a traditional flap. The trial compares two distinct materials used as the regenerative barrier: the control group utilizes a cortical lamina, which is a rigid bone plate known for its stability and slow resorption rate. The experimental group receives a magnesium membrane, an emerging class of "bioresorbable metals" that provides mechanical stability similar to titanium while releasing ions that stimulate bone-building cells and promote blood vessel growth. The study involves 24 patients who are monitored from baseline to six months post-surgery. The primary goal is to measure volumetric bone changes-specifically the thickness and height of the facial bone-using superimposed 3D scans (CBCT). Additionally, the protocol tracks secondary outcomes such as esthetic results via the Pink Esthetic Score, mucosal thickness, oral hygiene levels, patient-reported pain, and overall satisfaction with the restoration.

Вмешательства

• Процедура Immediate implant and VST using cortical lamina.
  Following a minimally traumatic removal of the denoted tooth, placement of bone-level implants using a prefabricated surgical stent is done with the implant shoulder placed 3 to 4 mm apical to the labial gingival margin Cortical bone shield (Lamina Osteobiol, Technoss, USA) is hydrated, trimmed, and packed through the vestibular access incision until it extended 1 mm below the socket orifice. It is then stabilized to the apical bone and the peri-implant space was filled with particulate xenograf
• Процедура Immediate implant and VST using Magnesium membrane.
  Following a minimally traumatic removal of the denoted tooth, placement of bone-level implants using a prefabricated surgical stent is done with the implant shoulder placed 3 to 4 mm apical to the labial gingival margin. A sterile, resorbable magnesium membrane (NovaMag, Botiss, Germany) is trimmed to the shape of the defect, inserted through the vestibular incision and stabilized to the apical bone to cover the facial defect, acting as a "bone shield and the peri-implant space was filled with

Первичные конечные точки

• Bone Volumetric changes [Срок оценки: Baseline and 6-months post-operative.]

Вторичные конечные точки (6)

• Peri-implant soft tissue esthetic outcome [Срок оценки: 6-months post-operative.]
• Peri-implant mucosal thickness [Срок оценки: Baseline and 6-months post-operative.]
• Plaque Index (PI) [Срок оценки: Baseline, 1 month, 3 months and 6 months.]
• Gingival Index (GI) [Срок оценки: Baseline, 1 month, 3 months, and 6 months.]
• Post-surgical Pain [Срок оценки: At 6, 12, and 24 hours post-operatively, then daily for 7 days.]
• Patient Satisfaction [Срок оценки: 6-months post-operative.]

Критерии участия

Критерии включения

• Single or multiple teeth with hopeless prognosis in maxillary anterior teeth with either type I or type II extraction sockets.
• Deficient labial bone plate in width (type I) and height (type II) sockets.
• Minimal of 3.0 mm basal bone present for immediate implant placement to achieve optimum primary stability.

Критерии исключения

• Current smokers.
• Patients with debilitating systemic disease.
• Patients who have undergone any sort of radiotherapy and chemotherapy in past 2 years.
• Pregnant and Lactating females.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Misr University for Science and Technology — Giza

Идентификаторы

NCT: NCT07526272 · 001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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