Comparison of incidence of difficulty of Surgical Removal of Mandibular Wisdom teeth with and without use of computerized printed 3D surgical guide

Phase 4

Not yet recruiting

• Conditions: Impacted teeth, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2023/12/060468
• Lead Sponsor: NEHAL AMBAVAT

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-12
• Study Start: 2023-12-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• . Age group between 18-60 years. 2. Impacted Mandibular third molar indicated for surgical removal. 3. Participants willing to participate in the study. 4. Mesioangular Impacted Mandibular Third Molar which need sectioning for surgical removal. 5. Horizontal Impacted Mandibular Third Molar which need sectioning for surgical removal. 6. Pederson difficulty index. (3-6) 7. 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. 7. 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.

Exclusion Criteria

• Fully erupted Mandibular third molars.
• Distoangular Impacted Mandibular Third Molar 3.
• Vertically Impacted Mandibular Third Molar 4.
• Acute infection with pericoronal /periodontal abscess 5.
• Medically compromised such as , diabetes, calcium deficiency, vitamin D deficiency, participants on Anti-coagulant medication, recent history of myocardial infarction.
• Pregnant women 7.
• Pre-existing dental pocket distal to 2nd molar 8.
• Missing Mandibular 2nd molar C)Withdrawal Criteria 9.
• Lone standing Impacted Mandibular third molar.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Pre operative evaluation before 24 hours of surgery. | Post operative evaluation at 24hours , 3rd day and 7th day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MGM Dental College and Hospital Kamothe; 🇮🇳 Mumbai, MAHARASHTRA, India

MGM Dental College and Hospital Kamothe

🇮🇳Mumbai, MAHARASHTRA, India

NEHAL AMBAVAT

Principal investigator

9820476276

nehalj43@gmail.com