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CTRI Number  CTRI/2023/12/060468 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 02/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of incidence of difficulty of Surgical Removal of Mandibular Wisdom teeth with and without use of computerized printed 3D surgical guide  
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nehal Ambavat  
Designation  Post- Graduate Student  
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL  
Address  Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, 4th Floor Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, 4th Floor Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Mumbai
MAHARASHTRA
410209
India 
Phone  9820476276  
Fax    
Email  nehalj43@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srivalli Natarajan  
Designation  Dean, Professor and Head of Department 
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL  
Address  Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, 4th Floor Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, 4th Floor Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Mumbai
MAHARASHTRA
410209
India 
Phone  9769088803  
Fax    
Email  srivalli.shrikanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NEHAL AMBAVAT  
Designation  Post- Graduate Student  
Affiliation  MGM DENTAL COLLEGE AND HOSPITAL  
Address  Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, 4th Floor Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Department of Oral and Maxillofacial Surgery, MGM Dental College and Hospital, 4th Floor Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Mumbai
MAHARASHTRA
410209
India 
Phone  9820476276  
Fax    
Email  nehalj43@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College and Hospital, Kamothe, Navi Mumbai 
 
Primary Sponsor  
Name  NEHAL AMBAVAT  
Address  MGM Dental College and Hospital Kamothe sector 1 and 2 mumbai panvel highway 410209 
Type of Sponsor  Other [SELF FUNDED ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
NEHAL AMBAVAT   MGM Dental College and Hospital Kamothe   Mgm Dental College and Hospital, Department of Oral and Maxillofacial surgery. 4th Floor, Room no 402, Plot 1 and 2, Sector 1, NH4 Junction, Mumbai- Pune Highway ,Kamothe, Navi Mumbai
Mumbai
MAHARASHTRA 
9820476276

nehalj43@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUSIONAL ETHICS COMMITTE MGM DENTAL COLLEGE AND HOSPITAL KAMOTHE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Surgical Extraction of Impacted Mandibular Third Molar Without use of Virtually printed 3D Surgical Guide   Conventional Surgical Method without using any 3D printed surgical guide would be used for extraction of Impacted Mandibular Third Molar  
Intervention  Virtually Printed 3D Surgical Guide for Extraction of Impacted Mandibular Third Molar   Virtually Printed 3D Surgical Guide for Extraction of Impacted Mandibular Third Molar  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  . 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 
 
ExclusionCriteria 
Details  Fully erupted Mandibular third molars.
2. 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.
6. 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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   26/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

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

 Traditionally periapical radiographs have been used diagnosis of the impacted teeth. The advantages of these radiographic technique are reduction in radiation and less magnification but one of the major disadvantages of periapical radiographs is Mandibular canal cannot be clearly identified. Also, the angulation of the radiograph can affect the position of the canal which can lead to misinterpretation of the apices of the impacted tooth in relation to Mandibular canal. However digital imaging, too, could not considerably help reduce the complications.

With the advent of this new technology and imaging system it is now possible to have an accurate knowledge about the regional anatomy. Preoperative CBCT and DICOM image files can help to obtain exact diagnosis, determine the proximity of Inferior Alveolar Nerve, amount of bone covering the third molar. The CBCT based DICOM images can be imported for virtual surgical planning where the area of interest can be segmented and the relations to anatomical structures can be viewed and accordingly the treatment plan for surgical extraction of impacted third molar can 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.

 

 
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