The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant With Transcrestal Sinus Lifting Technique: Randomized-Controlled CBCT Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- endo-sinus bone gain
研究概览
简要总结
The aim of this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application.
详细描述
Twenty-four patients will be randomly assigned into two groups: Group I: (EMD+OSFE) (n=20 implants, 13 patients) OSFE with EMD application, and Group II 8OSFE): (n=20 implants, 11 patients) OSFE without EMD application. The patients will be recall at 3- and 12- months after surgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), implant stability and peri-implant bone density values (Hounsfield units) will be assessed.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •partial edentulism in the maxillary posterior region for at least 4 months from tooth loss and require implant treatment
- •adequate bone thickness for primary stabilization
- •residual bone height ranged from 4 mm to 6 mm
- •systemic and local conditions compatible with implant placement and sinus floor elevation
- •antagonist teeth
排除标准
- •uncontrolled diabetes mellitus or other systemic disorders (such as; hepatitis, tuberculosis, AIDS)
- •pregnancy
- •untreated periodontal disease
- •endodontic lesions or other oral disorders
- •heavy smokers (≥10 cigarettes per day)
- •acute or chronic rhinitis
- •sinusitis or pathology in sinus
- •inadequate residual bone height and quality to achieve implant stability
- •previous implant treatment/failure or bone augmentation in the implant site
- •sinus perforation as confirmed via Valsalva maneuver
- •insufficient primary implant stability measured by RFA
研究组 & 干预措施
Transcrestal Sinus Lifting with Emdogain
Osteotome sinus floor elevation with enamel matrix derivated
干预措施: Enamel Matrix Protein (Drug)
Transcrestal Sinus Lifting
Osteotome sinus floor elevation
干预措施: Enamel Matrix Protein (Drug)
结局指标
主要结局
endo-sinus bone gain
时间窗: CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)
New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain
次要结局
- radiographic measurements(CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2))
- Radiographic measurements(CBCT will be evaluated at initiation of study (T0), and at 12th month (T2))
- implant stability(It will be measured at initiated at implant placement and third month follow-up)
- peri-implant sinus bone level(CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2))
- Densitometric Analysis(Bone Density was measured at baseline, 3- and 12-months by CBCT scans)
研究者
Berceste Guler
Assoc Prof
T.C. Dumlupınar Üniversitesi