跳至主要内容
临床试验/NCT07536620
NCT07536620尚未招募2 期

Does the Addition of Metformin to Autogenous Bone Graft Improve the Bone Quality After Alveolar Cleft Reconstruction? A Randomized Clinical Trial

Fayoum University0 个研究点目标入组 36 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: placebo group (Procedure)

metformin group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Mohsen

associate professor

Fayoum University

相似试验