Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration

Официальное название

Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study

Обзор

This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. The study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. Participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.

Вмешательства

• Процедура Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh
  Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration.In the bone grafting surgery, the additive-manufactured personalized titanium mesh is used to secure the bone substitutes, with fixation screws used to secure the titanium mesh.
• Процедура Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh
  In bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh.

Первичные конечные точки

• Osteogenesis efficiency [Срок оценки: 6 months after surgery]

Вторичные конечные точки (1)

• Incidence of titanium mesh exposure [Срок оценки: 14 days, 1 month, 6 months, 1 year, and 2 years after surgery]

Критерии участия

Критерии включения

• Patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration. （Moderate bone defects: bone loss with residual alveolar ridge width between 1 mm and 3 mm; severe bone defects: bone loss with residual alveolar ridge width ≤ 1 mm.）
• The edge of the edentulous area within 1 mm is alveolar bone, with no adjacent tooth roots or nerve canals, ensuring complete retention of the personalized titanium mesh edge. The apical edge of the edentulous area within 2 mm is alveolar bone, with no nerve canals, ensuring that retention screws for the personalized titanium mesh can be designed in this area.
• The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.

Критерии исключения

• Patients with edentulism.
• Patients with mild bone defects (residual alveolar ridge width greater than 3 mm).
• Presence of acute or chronic infection in the surgical area.
• Presence of acute or chronic infection in the teeth adjacent to the edentulous area.
• Participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form.
• History of metal allergies, severe allergy history, or severe immune deficiency.
• Uncontrolled metabolic diseases, such as Type 1 diabetes or Type 2 diabetes (HbA1c ≥ 7% or fasting blood glucose ≥ 7 mmol/L despite medication control), severe liver or kidney dysfunction (ALT, AST > 2 times the upper limit of normal, serum creatinine above the upper limit of normal).
• Long-term use of steroid medications.
• History of drug abuse or alcoholism.
• Pregnant or breastfeeding women.
• Poor compliance.
• Other conditions deemed unsuitable for participation by the investigator.

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

Китай · 1 центр

• Hospital of Stomatology, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06692244 · GHKQ-202408-L3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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