Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis)

Официальное название

Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis): A Randomized Clinical Trial

Обзор

The purpose of the study is the comparison of bone gained histologically from the Bone Shell Khoury's Technique in comparison with the usage of non-resorbable membrane polytetrafluoroethylene and discussing its eligibility for implant placement in restoring the atrophic posterior mandible.

Подробное описание

The aim of this study is to assess the bone gained histologically when comparing the following different techniques:

One of the techniques that is used for bone augmentation is the Khoury technique which entails that a split cortical bone shell obtained from the ramus area through piezoelectric surgery. The thin laminae of bone obtained is stabilized in the defect area labially through micro screws and the generated gap is filled through a mixture of autogenous that could be obtained from the retromolar area through special burs as the auto chip maker (ACM) or via bone scrapper. The obtained is mixed with an equal ratio with xenograft or bone obtained from animal source to fill the created gap.

Another technique involves the usage of a non-resorbable membrane known as reinforced titanium PTFE that is stabilized from both the lingual and labial aspects via micro screws .It's then filled with a mixture of both autogenous and xenograft for maximizing the bone formation capability. In some cases, the reinforced titanium PTFE is covered with collagen membrane to avoid one of the common drawbacks of this technique which is wound dehiscence.

This study aims to evaluate the bone quality gained from both techniques.

Вмешательства

• Процедура GBR using Ti based PTFE
  Patients will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane with full releasing flap buccal and lingual with the lingual dissection for the releasing of the mylohyoid attachment and nerve dissection of the mental nerve buccally. The membrane needs to be fixed lingually with microscrews or titanium screws then the gap will be filled through Auto Chip Maker ACM or bone scraper from the external oblique ridge. Then the harvested bone shall be mixed xeno
• Процедура Bone Shell Khoury's Technique
  A block graft using Khoury Technique: Prior to harvesting the needed bone, measurement of the defect size as well as measurement of the donor site bone block will be harvested from the mandibular retromolar area. The bone shall be acquired through piezoelectric device that perform the osteotomy then separated through the usage of thin chisel. The acquired bone needs to be smoothened to avoid any sharp edge that may cause wound dehiscence or infection. The harvested bone will be divided into two

Первичные конечные точки

• Histomorphometric analysis of gained bone [Срок оценки: 6 Months]

Критерии участия

Критерии включения

• Have two or more missing teeth in the posterior mandibular segment.
• The patients age of 18 and above.
• The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 4mm.
• Sufficient vertical bone height.
• Free of any local or systemic condition that may contraindicate ridge expansion procedure.

Критерии исключения

• Patients taking any medication that may interfere with bone healing or bone biology.
• Patients with any systemic disease that may affect bone healing.
• Any patients with any previous bone grafting procedure at the site of interest.
• Smokers.
• Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
• Patients with significant vitamin D deficiency.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• The British University in Egypt — Cairo

Идентификаторы

NCT: NCT07669792 · 25-018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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