| CTRI Number |
CTRI/2024/08/072447 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Outcomes after Deep Seated Third Molar Removal Using A Piezotome and A Conventional Rotary Handpiece |
|
Scientific Title of Study
|
Surgical Outcome After Impacted Third Molar Removal Using Piezotome and Conventional Rotary Handpiece :A Comparative 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 |
DrNeha Agarwal |
| Designation |
Post Graduate Student |
| Affiliation |
|
| Address |
DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7585952765 |
| Fax |
|
| Email |
nehu.agarwal1999@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.B.M.Rudagi |
| Designation |
HOD and Professor |
| Affiliation |
DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune |
| Address |
DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673494111 |
| Fax |
|
| Email |
drbmr17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR.B.M.Rudagi |
| Designation |
HOD and Professor |
| Affiliation |
DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune |
| Address |
DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673494111 |
| Fax |
|
| Email |
drbmr17@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
DRDY Patil Dental College and HospitaDR DY Patil Vidyapeeth Pimpri Pune |
| Address |
Department of Oral and Maxillofacial Surgery Dental OPD 9 DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrNeha Agarwal |
DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune |
Department of Oral and Maxillofacial Surgery Dental OPD 9 DR.DY Patil Dental College and Hospita,DR. DY Patil Vidyapeeth Pimpri Pune
Pune
MAHARASHTRA |
7585952765
nehu.agarwal1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee Dr.DY Patil Dental College and Hospital Dr.DY Patil Vidyapeeth Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Third molar surgery using a conventional rotary handpiece |
Guttering of bone around third molar using a conventional rotary handpiece for better accessibility |
| Intervention |
Third Molar Surgery using Piezotome |
Guttering of bone around third molar will be done using piezotome for better accessibility |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring surgical removal of impacted mandibular third molar
2.Teeth with same Pederson difficulty index
3.Patients who gave written informed consents |
|
| ExclusionCriteria |
| Details |
1.Immunocompromised individuals including those with severe or debilitating diseases
2.Pregnant,lactating,or female participants taking oral contraceptives. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters to be observed:
Postoperative pain
Oedema
Mouth opening |
1,3,5,7 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Parameters to be observed:
Postoperative pain
Oedema
Mouth |
Postoperative day 2,4,6,8 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/11/2024 |
| 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="0"
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
|
 One of the most performed surgical procedures by oral and maxillofacial surgeons all over the world is the removal of impacted teeth. The most critical and important steps in third molar extraction are bone cutting or osteotomy. Many techniques are used for this purpose including chisels and mallet, rotary instruments, and ultrasonicâ€based bone cutting instruments. Piezotome is newer and innovative device for osteotomy based on piezoelectric vibrations. Piezotome is considered very efficient in performing osteotomy because of its selective cutting; being inert against soft tissues, including nerves and blood vessels.The Objective of the study is to assess the efficacy of piezotome in third molar surgery,to assess the efficacy of a conventional rotary handpiece,to compare overall surgical outcomes such as postoperative pain, oedema, mouth opening following third molar surgery using conventional rotary technique and piezotome.
The study is being conducted to confirm the outcomes of reduced postoperative pain and postoperative oedema and improved mouth opening when using a piezotome rather than a conventional rotary handpiece.
|