Clinical and Radiographic Evaluation of the Effect of Thymoquinone 0.2% Gel on Bone Density, Bone Width, and Socket Preservation After Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in alveolar bone density after tooth extraction
研究概览
简要总结
This study aims to evaluate the clinical and radiographic effects of 0.2% Thymoquinone gel on bone density, bone width, and socket preservation after tooth extraction.
详细描述
Tooth extraction triggers a cascade of biological events which lead to significant remodeling of the alveolar ridge, frequently resulting in reductions in both bone width and height.
The concept of alveolar ridge preservation (ARP) has developed to address the bone resorption that follows extraction. ARP aims to maintain ridge dimensions and reduce the need for further augmentation before implant placement.
Among these, the small-molecule Thymoquinone (TQ), derived from Nigella sativa, has demonstrated significant osteogenic, anti-inflammatory, and antioxidant effects in preclinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-50 years.
- •Both sexes.
- •Patients requiring extraction of upper posterior teeth will be recruited.
排除标准
- •Healthy subjects with intact sockets after extraction.
- •Normal mouth opening and good oral hygiene.
- •No systemic conditions affecting bone healing.
研究组 & 干预措施
Group I (Negative Control)
Patients will receive gel foam only
干预措施: Gel foam (Drug)
Group II (Study Group 1)
Patients will receive 0.2% thymoquinone gel + gel foam.
干预措施: Thymoquinone gel + gel foam (Drug)
Group III (Study Group 2, Nano)
Patients will receive nano-formulated 0.2% thymoquinone gel + gel foam.
干预措施: Nano-formulated 0.2% thymoquinone gel + gel foam (Drug)
结局指标
主要结局
Change in alveolar bone density after tooth extraction
时间窗: 3 months after tooth extraction
Alveolar bone density will be assessed radiographically using cone-beam computed tomography (CBCT). The change in bone density from baseline to the specified postoperative assessment will be compared.
次要结局
- Change in alveolar bone width after tooth extraction(3 months after tooth extraction)
- Change in alveolar ridge dimension after tooth extraction(3 months after tooth extraction)
研究者
Muataz Adnan Karimeh
Oral and Maxillofacial Surgery, Faculty of Dentistry, Kafrelsheikh University, Kafrelsheikh, Egypt.
Kafrelsheikh University