Therapeutic Wavelength Nanotechnology Devices in Alveolar Preservation

Официальное название

Evaluation of Low-Intensity Therapeutic Wavelength Nanotechnology Devices in Alveolar Preservation: A Clinical Trial

Обзор

After tooth extraction, a progressive alveolar bone resorption is observed. Alveolar ridge preservation consists of placing a biomaterial within the extraction socket and covering it with a membrane. This procedure helps limit physiological bone resorption, making the soft and hard tissue profile of the edentulous site more prosthetically favorable.

Подробное описание

After tooth extraction, a progressive remodeling process occurs that is often associated with significant alveolar bone resorption, particularly in sites with compromised bony walls. Alveolar ridge preservation is a surgical procedure aimed at minimizing this physiological resorption by placing grafting materials within the extraction socket and protecting them with a barrier membrane.

In the present protocol, the socket is filled with a xenogeneic bone graft enriched with hyaluronic acid, which enhances biological activity by promoting angiogenesis, cell migration, and early wound healing. The grafted site is then covered with a dermal matrix membrane, providing mechanical protection, stabilization of the biomaterial, and guided tissue regeneration.

In one study group, in addition to the surgical procedure, postoperative biostimulation using low-intensity photonic nanotechnology is applied. This adjunctive therapy is intended to enhance cellular metabolism, modulate inflammation, and accelerate both soft and hard tissue healing. The combined approach aims to preserve alveolar volume more effectively, improve the quality of regenerated tissues, and create a more favorable prosthetic environment for subsequent implant rehabilitation.

Вмешательства

• Процедура Socket Preservation
  After atraumatic tooth extraction, the socket is filled with a xenogeneic bone graft enriched with hyaluronic acid, which enhances biological activity by promoting angiogenesis, cell migration, and early wound healing. The grafted site is then covered with a dermal matrix membrane, providing mechanical protection, stabilization of the biomaterial, and guided tissue regeneration.

Первичные конечные точки

• VAS [Срок оценки: 1 day , 3 days , 7 days ,14 days]
• Analgesic consumption [Срок оценки: 7 days]

Вторичные конечные точки (1)

• Histological Evaluation [Срок оценки: 4- 6 month]

Критерии участия

Критерии включения

• Adults in good general health
• Indication for tooth extraction in sites planned for delayed implant placement
• Inability to place immediate post-extraction implants due to insufficient residual bone to ensure primary stability
• Extraction sockets presenting absence of the buccal (vestibular) bone wall
• Signed informed consent

Критерии исключения

• Systemic conditions affecting bone healing
• Uncontrolled periodontal disease
• Smoking >10 cigarettes/day
• Pregnancy or lactation
• Use of medications interfering with bone metabolism

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07371130 · AlveolarPreservation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗