The Impact of Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants
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
- Assessment of Implant primary stability
研究概览
简要总结
This study aimed to investigate whether combining xenografts with Metformin Gel gel enhances bone regeneration and improves implant outcomes.
详细描述
The placement of a dental implant in an extraction socket at the time of extraction or explanation is known as immediate implant placement whereas delayed placement of implant signifies the implant placement in edentulous areas where healing has completed with new bone formation after the loss of tooth/teeth.
The xenograft is derived from other organisms, mainly bovine. It provides long-term volume stability. Porous natural hydroxyapatite can be obtained from animal bones.
Metformin HCl (1, 1-dimethylbiguanide HCl) (MF), is one of the most commonly used oral anti-hyperglycemic agents for the treatment of type 2 diabetes mellitus. The use of MF may reduce the association between diabetes and fractures in patients with both type 1 and type 2DM.MF increase type I collagen production in osteoblast-like cell lines and stimulated alkaline phosphate activity in osteoblasts.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 40 years.
- •Both sexes.
- •Adult individual with non-restorable tooth in esthetic and premolars area and seeking for immediate implant placement.
- •Systemically healthy patients were selected for implant surgery according to the criteria of Cornell medical index and its modifications.
- •The recipient site of the implant should be free from any pathological conditions.
- •Sufficient vertical bone height to safely place at least 12 mm long dental implant.
排除标准
- •Pregnant or lactating female patients.
- •Patients with parafunctional habits such as bruxism and clenching.
- •Presence of acute infection around the failing tooth.
- •Perforation and/or loss of the labial bony plate following tooth removal and/or implant osteotomy.
- •Inability to attain primary implant stability following immediate implant placement.
研究组 & 干预措施
Group I
Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft.
干预措施: Metformin gel-xenograft (Other)
Group II
Patients received immediate implant combined with xenograft alone.
干预措施: Xenograft (Other)
结局指标
主要结局
Assessment of Implant primary stability
时间窗: 12 months after implant placement
Implant primary stability was assessed using Resonance Frequency Analysis at baseline and at 3, 6, and 12 months after implant placement.
次要结局
- Soft tissue change of modified Plaque Iindex(12 months after implant placement)
- Soft tissue change of modified sulcus bleeding index(12 months after implant placement)
- Soft tissue change of peri-implant probing depth(12 months after implant placement)
- Radiographic Evaluation to horizontal jumping gap(12 months after implant insertion)
- Radiographic Evaluation to buccal bone thickness(12 months after implant insertion)
- Biochemical assessment of peri-implant crevecular fluid level(3 months after implant placement)
研究者
Ibrahim Gamal Abd El Wahab
B.D.S of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology, Faculty of Dental Medicine
Al-Azhar University