Clinical, Radiographic and Histomorphometric Assessment of the Effect of Melatonin Gel Mixed With Xenograft in Augmentation of the Maxillary Sinus: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Alveolar Bone Height
研究概览
简要总结
The possibility of enhancing the bone substitute in the maxillary sinus by mixing it with the melatonin to allow proper implant placement in early stage .
The aim of the study was to evaluate clinically, radiographically and histologically the effect of melatonin in enhancement of bone healing after augmentation of the maxillary sinus.
详细描述
This study was include 16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement, they were be equally and randomly distributed into 2 groups (via : http://www.randomizer.org) :
Group A: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with the mixture of melatonin and xenograft.
Group B: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with xenograft.
After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit.
Initial cone beam computerized tomography was taken preoperatively and immediate postoperatively.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male/female patients above the age of
- •Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
- •Alveolar bone height less than 4 mm at the defective site.
- •Good oral hygiene.
排除标准
- •Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- •Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- •Heavy smokers.
- •Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).
研究组 & 干预措施
group a: xenograft mixed with melatonin
in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft mixed with melatonin gel to enhance the bone healing
干预措施: Open sinus augmentation with melatonin gel mixed with xenograft (Dietary Supplement)
group b: xenograft
in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives
干预措施: Open sinus augmentation with xenograft (Procedure)
结局指标
主要结局
Alveolar Bone Height
时间窗: 8 months
Alveolar Bone height was measured using cone beam computed tomography (CBCT).
次要结局
- Histological Analysis of Newly Formed Bone(8 months)
研究者
rehab soliman
lecturer of oral and maxillofacial department
Ain Shams University