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
|
|
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
|
|
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.
|