Does the Addition of Metformin to Autogenous Bone Graft Improve the Bone Quality After Alveolar Cleft Reconstruction? A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- bone density
研究概览
简要总结
-
Completed medical history will take for all patients. All patients' guardians were informed about the procedure, the possible postoperative complications, and requested to sign an informed consent that was translated into Arabic language.
-
Patients were randomly divided into two equal groups by means of sealed envelopes:
-
Group A ( study group) 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose)
-
Group B (control group): 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose) Preparation of the Donor Site (Anterior Iliac Crest) and Harvesting of the Bone Graft
-
A standard incision will be done to expose the anterior iliac crest. The cancellous bone graft will be harvested using 8 mm diameter trephine bur (KLS Martin, city, Germany). The graft will be harvested by molt and surgical curettes. The wound was then closed in the usual manner.
-
For group A, the patients will receive iliac bone graft mixed with metformin gel and packed into the defect While in group B, the iliac bone graft will be mixed with placebo gel and packed into the defect.
-
The labial flap was then approximated to the palatal one and sutured over the cleft area beginning with a horizontal mattress suture followed by multiple interrupted sutures to completely cover the grafted area
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with no syndromic unilateral alveolar cleft.
- •Patients' ages observed between 8 and 12 years.
排除标准
- •Syndromic cases will be excluded
- •Previous operated cases
研究组 & 干预措施
placebo group
干预措施: placebo group (Procedure)
metformin group
干预措施: metformin group (Procedure)
结局指标
主要结局
bone density
时间窗: 6 months postoperative
by cone beam ct
次要结局
未报告次要终点
研究者
Shaimaa Mohsen
associate professor
Fayoum University
