Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Acemannan Aloe Vera Powder Extract Versus Normal Socket Healing. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in radiographic horizontal ridge width at 4 mm below the most coronal aspect of the crest
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of acemannan aloe vera powder extract in preserving the alveolar ridge following tooth extraction in healthy adult patients. It will also assess the healing process by radiographic and histomorphometric analyses. The main questions it aims to answer are:
Does acemannan aloe vera powder extract improve alveolar ridge preservation compared with natural socket healing? Does the use of acemannan aloe vera powder extract enhance bone quality and new bone formation as assessed by radiographic and histomorphometric outcomes?
Researchers will compare sockets treated with acemannan aloe vera powder extract to sockets allowed to heal naturally to determine whether the intervention results in improved dimensional preservation of the alveolar ridge and enhanced bone regeneration.
Participants will:
Undergo tooth extraction according to the study protocol. Be randomly assigned to receive either acemannan aloe vera powder extract for alveolar ridge preservation or natural socket healing without grafting.
Attend scheduled follow-up visits for clinical and radiographic evaluations. Undergo radiographic assessment using cone-beam computed tomography (CBCT) to evaluate changes in alveolar ridge dimensions.
Provide a bone biopsy at the time of implant placement for histomorphometric analysis of new bone formation and tissue composition.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Non-restorable tooth in maxillary or mandibular anterior esthetic region.
- •Intact or minimally affected buccal plate of bone.
- •Patients at least 18 years or older.
- •Motivated patients, agree to sign the written informed consent and complete the follow-up period.
排除标准
- •Infection at the extraction site.
- •Smokers more than 10 cigarettes per day .
- •Patients undergoing or having a history of radiotherapy, chemotherapy, or bisphosphonate therapy .
- •Systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism) .
- •Patients on medication that may interfere with healing (Corticosteroids, Bisphosphonate, Chemo/radio therapy)
- •Systemic diseases or medications that affect blood clotting
- •Pregnant females or those planning to get pregnant during the study period (American Dental Association, 2011).
结局指标
主要结局
Change in radiographic horizontal ridge width at 4 mm below the most coronal aspect of the crest
时间窗: 6 months postoperatively
The immediate postoperative scans served as the baseline and were evaluated after 6 months to assess horizontal ridge width. Employing the same software, standardized measurements were obtained at both time points using consistent anatomical landmarks. On each baseline and after 6 months images, the apical point of the extraction socket was identified, and a vertical line was drawn through the socket's midpoint. A horizontal reference line perpendicular to the vertical axis was then established at the apical point. Horizontal ridge width was measured at 4 mm below the crest, yielding the parameters HW-4
次要结局
- Horizontal ridge width was measured at 2 mm and 6 mm below the crest(6 months postoperatively)
- Vertical ridge height(6-months post)
- Percentage of new vital bone formation(6 months post)
研究者
Nouf Saeed Ahmed Alamoudi
Principal Investigator Nouf Alamoudi Master Degree student, Dental Imlantology department, Faculty of Dentistry, Cairo University
Cairo University