Bone Augmentation Techniques in the Mandible Posterior Region

Официальное название

Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial

Обзор

This study will compare three methods to rebuild lost bone in the back part of the lower jaw (posterior mandible) before dental implant placement. Seventy-eight adults will be randomly assigned to receive one of three "cortical shell" techniques using either the patient's own bone (autogenous) or prefabricated bone plates from animal (xenogeneic) or human donors (allogeneic). In all groups, the space inside the shell will be filled with a mixture of small bone chips and bone substitute material. The main outcome is the increase in jawbone width measured on 3D cone-beam CT scans at 6 months after surgery. Additional scans and clinical assessments up to 12 months will evaluate healing, bone stability, and postoperative recovery.

Вмешательства

• Процедура Cortical Shell Bone Grafting
  Surgical reconstruction of atrophic posterior mandibular ridges using thin cortical plates fixed with titanium microscrews to form a biologic shell. The inner space is filled with a 1:1 mixture of autogenous bone chips and biomaterial. Depending on the study group, the cortical plates are autogenous (from the mandibular ramus), xenogeneic (bovine origin), or allogeneic (human donor).

Первичные конечные точки

• Horizontal Bone Gain (mm) Measured by CBCT [Срок оценки: 6 after surgery]

Вторичные конечные точки (6)

• Surgical Duration (minutes) [Срок оценки: Day 0 (intraoperative measurement)]
• Relative Radiographic Density Using CBCT Gray Value Units [Срок оценки: 3, 6, and 12 months after surgery]
• Postoperative Inflammation (mm Facial Measurement) [Срок оценки: Preoperative, immediate postoperative, days 3, 7, and 14]
• Volumetric Bone Gain (mm³) [Срок оценки: 3, 6, and 12 months after surgery]
• Morphometric Surface Deviation (mm) [Срок оценки: 3, 6, and 12 months after surgery]
• Secondary Horizontal Bone Gain at 3 and 12 Months [Срок оценки: 3 and 12 months after surgery]

Критерии участия

Критерии включения

Posterior mandibular edentulism requiring horizontal ridge augmentation (Cawood \& Howell Classes IV-VI).

One or two eligible posterior mandibular sites suitable for cortical shell augmentation.

Adequate residual bone height to allow safe fixation above the mandibular canal.

Good general health (ASA I or II). Plaque index < 20% and absence of active periodontal infection. Ability and willingness to attend scheduled follow-up visits (up to 12 months). Written informed consent provided prior to any study-related procedure.

Критерии исключения

Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).

Current heavy smoking (>5 cigarettes/day). Pregnancy or lactation. Current use of medications known to affect bone metabolism or healing (e.g., bisphosphonates, long-term corticosteroids, anticoagulants).

Active periodontal disease or untreated oral infection. History of chemotherapy or radiotherapy to the head and neck region.

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

Открытое

Основная цель

Лечение

Центры проведения

Ecuador · 1 центр

• Universidad Espíritu Santo — Samborondón

Идентификаторы

NCT: NCT06661447 · 2024-ODONT-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗