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临床试验/CTRI/2023/12/060468
CTRI/2023/12/060468尚未招募4 期

Comparative Evaluation of incidence of complications of Surgical Extraction of Impacted Mandibular Third Molar with and without use of virtually planned surgical guide : A Prospective Randomized Control Study.

NEHAL AMBAVAT1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年12月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
To evaluate and compare the incidence of complications of surgical extraction of impacted mandibular third molar with and without use of virtually planned surgical guide

研究概览

简要总结

Disimpaction of Mandibular thirdmolar is a common minor oral surgical procedure which can be problematic with asignificant incidence of iatrogenic complications. Causative factors forcomplications associated with disimpaction have been reported to be age,infection history, operator skills and type of impaction. The anatomic relationof third molar roots to the inferior alveolar nerve forms the most importantfactor amongst all the other factors.

Traditionally periapical radiographs have beenused diagnosis of the impacted teeth. The advantages of these radiographictechnique are reduction in radiation and less magnification but one of themajor disadvantages of periapical radiographs is Mandibular canal cannot beclearly identified. Also, the angulation of the radiograph can affect theposition of the canal which can lead to misinterpretation of the apices of theimpacted tooth in relation to Mandibular canal. However digital imaging, too,could not considerably help reduce the complications.

With the advent of this newtechnology and imaging system it is now possible to have an accurate knowledgeabout the regional anatomy. Preoperative CBCT and DICOM image files can help toobtain exact diagnosis, determine the proximity of Inferior Alveolar Nerve,amount of bone covering the third molar. The CBCT based DICOM images can beimported for virtual surgical planning where the area of interest can besegmented and the relations to anatomical structures can be viewed andaccordingly the treatment plan for surgical extraction of impacted third molarcan be planned with a guided model.

Thus the rationale of this study is to come up with methods to reduce the incidence of complications related to surgical extraction of impacted Mandibular third molar with virtually planned surgical guide for precise osteotomy and odontectomy for minimally invasive procedure and enhanced clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • . Age group between 18-60 years.
  • Impacted Mandibular third molar indicated for surgical removal.
  • Participants willing to participate in the study.
  • Mesioangular Impacted Mandibular Third Molar which need sectioning for surgical removal.
  • Horizontal Impacted Mandibular Third Molar which need sectioning for surgical removal.
  • Pederson difficulty index. (3-6)
  • Position B or position C.
  • Based on the Depth of the Impacted Mandibular molar in relation to 2nd molar as per Pell and Gregory Classification.
  • Class I, Class II and Class III as per the available space between the distal aspect of 2nd molar and anterior margin of Mandibular ramus.

排除标准

  • Fully erupted Mandibular third molars.
  • Distoangular Impacted Mandibular Third Molar
  • Vertically Impacted Mandibular Third Molar
  • Acute infection with pericoronal /periodontal abscess
  • Medically compromised such as , diabetes, calcium deficiency, vitamin D deficiency, participants on Anti-coagulant medication, recent history of myocardial infarction.
  • Pregnant women
  • Pre-existing dental pocket distal to 2nd molar
  • Missing Mandibular 2nd molar C)Withdrawal Criteria
  • Lone standing Impacted Mandibular third molar.

结局指标

主要结局

To evaluate and compare the incidence of complications of surgical extraction of impacted mandibular third molar with and without use of virtually planned surgical guide

时间窗: Pre operative evaluation before 24 hours of surgery. | Post operative evaluation at 24hours , 3rd day and 7th day

次要结局

  • To evaluate and compare the intra operative time taken for surgical extraction of impacted third molar with and without use of virtually planned surgical guide(Intra operative evaluation)

研究者

发起方
NEHAL AMBAVAT
申办方类型
Other [SELF FUNDED ]

研究点 (1)

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