Comparative evaluation of fully guided, pilot guided and freehand surgical protocols on accuracy of implant position in mandibular posterior partial edentulous region: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Angular deviation
研究概览
简要总结
In this clinical trial, dental implants will be placed by fully guided, pilot guided and freehand surgical implant protocols in partially edentulous mandibular posterior region. The implants will be planned with CBCT and after intraoral scanning, the DICOM and STL files obtained will be merged and fabrication of guides will be done. The accuracy of implant position will be evaluated and compared for all three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 25 and 60 years Good general health with signed informed consent Good oral hygiene with full mouth plaque score Systemically healthy subjects requiring and opting dental implants for partial edentulous space of atleast 2 neighbouring teeth in mandibular posterior region.
- •Clinical situation fit for implantation as judged by the examining physician or principal investigator (satisfactory soft and hard tissue conditions and occlusion).
排除标准
- •Pregnant or lactating females Bisphosphonate treatment (either at the time of screening or in the history) Radiotherapy, irradiation of the mandible or the maxilla (either at the time of screening or in the history) INR more than 2.
- •Known HIV, Hepatitis B or Hepatitis C infection.
- •Known allergy to any component of the implant or the implant guide.
- •Untreated periodontal disease and or caries Conditions that might render intraoral manipulation impossible (limited mouth opening, excessive gag reflex.
结局指标
主要结局
1. Angular deviation
时间窗: Baaseline and 1 week
2. Linear deviation at coronal (mm)
时间窗: Baaseline and 1 week
a.Linear Facio-Lingual deviation at coronal(mm)
时间窗: Baaseline and 1 week
b.Linear Mesio-Distal deviation at coronal (mm) c.Linear Apico-Coronal deviation at coronal (mm)
时间窗: Baaseline and 1 week
3. Linear deviation at apex (mm)
时间窗: Baaseline and 1 week
a.Linear Facio-Lingual deviation at apex (mm)
时间窗: Baaseline and 1 week
b.Linear Mesio-Distal deviation at apex (mm)
时间窗: Baaseline and 1 week
c.Linear Apico-Coronal deviation at apex (mm)
时间窗: Baaseline and 1 week
次要结局
未报告次要终点
研究者
Dr Vaishali Madavi
Government Dental College and Hospital, Nagpur