Evaluation of Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants in Mandibular Posterior Region (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
- 14
- 试验地点
- 1
- 主要终点
- change in implant stability
研究概览
简要总结
Background: Patient specific surgical guides (PSG) have been widely used to achieve a precise 3D implant position. However, they prevent external cooling systems from reaching the osteotomy site sufficiently. So, heat generated during guided implant surgery is greater than free hand technique. Adding internal irrigation channel to the conventional surgical guides allows better diffusion of irrigation to the osteotomy site and reduces heat generation.
Aim of the study: Is to introduce a patient specific surgical guide design with internal irrigation system and compare it to the conventional surgical guide with external irrigation clinically through bone temperature, implant stability and radiographically by CBCT through crestal bone loss and bone density.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with missing mandibular posterior premolar or molar teeth.
- •Tooth extraction at the implant sites was performed at least 4 months before the surgery.
- •Residual alveolar bone height more than 10 mm.
- •With minimum alveolar bucco-lingual dimension of 6 mm.
- •Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
排除标准
- •Severe atrophic alveolar ridge (height less than 10mm, width less than 6mm).
- •Bad oral hygiene ( Silness-Löe index (score 2-3).
- •Heavy smoker (smoke greater than or equal 25 cigarettes per day).
- •Presence of acute infections or periapical lesions in adjacent teeth.
- •Parafunctional habits.
- •Pregnant females.
研究组 & 干预措施
Control group
干预措施: Conventional implant surgical guide with external irrigation (Other)
Study group
干预措施: Implant surgical guide with internal irrigation (Other)
结局指标
主要结局
change in implant stability
时间窗: Baseline and 4 months
Osstell will be used to objectively and non-invasively determine implant stability and to assess the progress of osseointegration without jeopardizing the healing process. This method is based on determining whether or not an implant is stable enough. The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant
change in postoperative oedema
时间窗: 2nd day, 1 week and 2 weeks
This will be measured as follows: None (no inflammation). Mild (intraoral swelling confined to the surgical field). Moderate (extraoral swelling in the surgical zone). Severe (extraoral swelling spreading beyond the surgical zone).
次要结局
- Presence of intra or postoperative complications(4 months)
- change in crestal bone loss(baseline and 4 months)
- change in bone density(baseline and 4 months)
研究者
Hams Hamed Abdelrahman
Assistant Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University