Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy

Официальное название

Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy

Обзор

This clinical trial aims to evaluate the effectiveness of an odontogenic graft obtained from extracted human teeth, with and without adjunctive low-level laser therapy (LLLT), on bone regeneration following posterior tooth extraction in systemically healthy adult patients. The study investigates whether the combination of autogenous tooth-derived graft material and LLLT enhances alveolar bone healing and preservation compared to grafting alone, prior to implant-supported posterior rehabilitation.

Подробное описание

This prospective clinical trial will include systemically healthy adult patients who require extraction of at least two posterior teeth with a hopeless prognosis due to periodontal disease, root caries, or root fractures, and who are candidates for implant-supported posterior rehabilitation. Following atraumatic tooth extraction, only sites with intact alveolar socket walls will be included.

Extracted teeth will be processed to obtain an autogenous odontogenic graft material. Eligible extraction sockets will be allocated to one of the study groups: (1) odontogenic graft alone or (2) odontogenic graft combined with adjunctive low-level laser therapy. In the laser group, LLLT will be applied according to a standardized protocol during the early healing period to promote cellular activity and bone regeneration.

Clinical and radiographic evaluations will be performed at baseline and at predefined follow-up intervals to assess soft tissue healing, bone dimensional changes, and quality of regenerated bone prior to implant placement. The primary outcome measure will be the amount and quality of newly formed bone, while secondary outcomes will include socket healing, postoperative morbidity, and implant feasibility.

The results of this study aim to provide clinical evidence on the potential benefits of combining autogenous tooth-derived grafts with low-level laser therapy for alveolar ridge preservation and to support optimized treatment protocols for implant-supported posterior rehabilitation.

Вмешательства

• Биопрепарат Autogenous Tooth-Derived Bone Graft
  Autogenous Tooth-Derived Bone Graft prepared using the BonMaker® ATB device from extracted human teeth. Following atraumatic tooth extraction, teeth will be mechanically ground and chemically processed according to the manufacturer's standardized protocol to obtain particulate autogenous graft material containing dentin and enamel components. The graft material will be placed immediately into extraction sockets for alveolar ridge preservation prior to implant placement.
• Устройство Low-Level Laser Therapy (LLLT)
  Adjunctive low-level laser therapy (LLLT) performed using a 650 nm diode laser device (Woodpecker DTE D-Laser Blue) with a 6 mm fiber applicator in continuous contact mode at an output power of 25 mW and an energy density of 0.500 J/cm². Laser irradiation will be applied to grafted extraction sockets immediately after extraction, after flap closure, and during postoperative follow-up visits according to a standardized treatment protocol to enhance soft tissue healing and bone regeneration.

Первичные конечные точки

• Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT) [Срок оценки: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]

Вторичные конечные точки (1)

• Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT) [Срок оценки: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]]

Критерии участия

Критерии включения

• Patients requiring tooth extraction due to periodontal reasons (teeth with a hopeless prognosis), root caries, or root fractures, who are simultaneously candidates for posterior replacement with an osseointegrated implant, and who require extraction of at least two teeth.
• Integrity of the alveolar socket walls following tooth extraction.
• Patients who accept the study conditions, sign written informed consent, and agree to attend the scheduled follow-up visits.

Критерии исключения

• General contraindications for dental and/or surgical treatments.
• Inflammatory or autoimmune diseases of the oral cavity.
• Uncontrolled diabetes mellitus (HbA1c > 7%).
• History of malignancy requiring chemotherapy or radiotherapy within the past 5 years.
• Previous treatment with immunosuppressive agents, bisphosphonates, or high-dose corticosteroids.
• Smoking more than 10 cigarettes per day.
• Pregnant or breastfeeding women.

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

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Health Sciences University — Istanbul

Идентификаторы

NCT: NCT07615361 · 85

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗