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Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy

2026年5月22日 更新者:Ayşe Toraman、Istanbul Saglik Bilimleri University

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

21

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Control Group
Dentin graft socket preservation
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.
实验性的:Test Group
Dentin graft socket preservation+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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
大体时间:Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)

Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement.

The primary outcome will be defined as the mean change in ridge width (Δ width = width at 4 months - width at baseline), expressed in millimeters.

Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)

次要结果测量

结果测量
措施说明
大体时间
Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
大体时间:Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]

Vertical alveolar ridge height will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement.

The secondary outcome will be defined as the mean change in ridge height (Δ height = height at 4 months - height at baseline), expressed in millimeters.

Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]

其他结果措施

结果测量
措施说明
大体时间
Percentage of Newly Formed Bone Measured by Histomorphometric Analysis of Bone Biopsy Specimens
大体时间:Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
Bone biopsy specimens obtained from grafted extraction sockets during implant placement surgery will be processed with hematoxylin and eosin (H&E) staining and evaluated under light microscopy. Histomorphometric analysis will be used to quantify the percentage of newly formed bone within the biopsy samples.
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月2日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年2月23日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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