A Clinical and Experimental Study to Evaluate the Efficacy of Locally Applied Hyaluronic Acid in Bone Healing Following Dental Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vertical bone fill
研究概览
简要总结
This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose case requires bilateral extraction, one side will serve as an experimental side, whereas the other side will serve as a control.
Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic acid will be injected following extraction in one of the two sides with random allocation.
cone-beam computerized tomography (CBCT) images will be taken for each participant immediately post-extraction and at six months post-operatively.
详细描述
I- Clinical examination variables:
Buccolingual distance and distomesial distance will be measured for each participant at 2 assessment times: directly post-extraction and six months post-extraction.
II- Radiographic examination variables:
Linear measurements Vertical bone fill Bone mineral density
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years old
- •Symmetric teeth requiring extraction in the lower jaw
- •Systematically healthy
排除标准
- •Pregnancy (for female participants)
- •Diabetic patients
- •Patients with metabolic problems
研究组 & 干预措施
Hyaluronic Acid Group
In this Group, Hyaluronic acid will be injected following extraction.
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Vertical bone fill
时间窗: This variable is going to be measured at 6 months post-extraction
'Vertical bone fill' is the distance between the base of the extraction socket and cement-enamel junction directly after extraction and minus the distance between base of the extraction socket and cement-enamel junction six months post-extraction. This variable is going to be measured on CBCT images.
Change in bone mineral density (BMD)
时间窗: (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.
BMD is the amount of bone tissue in a certain volume of bone. This variable is going to be measured on CBCT images.
次要结局
- Buccolingual distance(at six months post-extraction)
- Mesiodistal distance(at six months post-extraction)