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CTRI Number  CTRI/2023/06/054276 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 16/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three different methods in Surgical extractions of partially erupted Mandibular Third Molars using Piezo-Surgery and Piezo-surgery with steroid injections or rubber drain.  
Scientific Title of Study   Comparative Evaluation of Post-operative Outcomes following Surgical removal of Impacted Mandibular Third Molars using Piezo Surgery, Piezo Surgery with Submucosal Dexamethasone and Piezo Surgery with Surgical Drain. A Prospective Clinical Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prathamesh Moreshwar Dhore 
Designation  PG student 
Affiliation  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh

Raigarh
MAHARASHTRA
410209
India 
Phone  7276475361  
Fax    
Email  prathamesh.dhore@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srivalli Natrajan 
Designation  Professor and HOD 
Affiliation  Professor and HOD under OMFS 
Address  MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh

Raigarh
MAHARASHTRA
410209
India 
Phone  9769088803  
Fax    
Email  srivalli.shrikanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Adil Gandevivala 
Designation  Professor and Guide 
Affiliation  Reader under OMFS 
Address  MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh

Raigarh
MAHARASHTRA
410209
India 
Phone  9096815606  
Fax    
Email  dr.adilg@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh 
 
Primary Sponsor  
Name  MGM Dental College and Hospital 
Address  MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh 
Type of Sponsor  Private medical college 
 
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 
Dr Prathamesh Dhore  MGM Dental College and Hospital  MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh
Raigarh
MAHARASHTRA 
7276475361

prathamesh.dhore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGM Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Submucosal Dexamethasone  8 mg submucosal Dexamethasone will be administered intra operatively as a single dose  
Intervention  Surgical extraction with Piezo-surgery  Surgical extraction of third molar will be done using piezo-surgery and post operative sequelae will be noted. 
Comparator Agent  Surgical extraction with piezo-surgery with surgical drain  Surgical extraction of third molar will be done using piezo-surgery with surgical drain and post operative sequelae will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Impacted mandibular third molars with Pederson’s difficulty score between 5 to 7.
Male and female participants in the age group of 18-45 years.
Participants willing to participate in the study.
 
 
ExclusionCriteria 
Details  Patients with known allergies to local anaesthetics, antibiotics and analgesics.
Pregnancy and lactation.
Systemic diseases
Bone metabolism disorder.
Signs of active infection and inflammation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the post operative swelling with the use of Piezo-surgery, Piezo-surgery with submucosal dexamethasone, Piezo-surgery with surgical drain after the extraction of impacted mandibular third molars.  Post operatively follow up will be done at 1st, 3rd and 7th day.
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the post operative pain with the use of Piezo-surgery, Piezo-surgery with submucosal dexamethasone, Piezo-surgery with surgical drain after the extraction of impacted mandibular third molars.  Post operatively follow up will be done at 1st, 3rd and 7th day.
 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   16/07/2023 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Surgical extraction of the impacted third molar is one of the most performed surgical procedures in the field of Oral and Maxillofacial Surgery. Assessment of third molars surgery in terms of indications, surgical techniques, symptoms, and postoperative sequelae becomes a necessity to offer patients high quality care and minimize their suffering. One of the most important steps in mandibular third molar surgery is the removal of the covering bone or osteotomy, for which many techniques are used. The most recent technique includes the use of Piezo-surgery. The piezoelectric instrument produces a modulated ultrasonic frequency of 24–29 kHz and a microvibration amplitude between 60 and 200 mm/s. The amplitude of these microvibrations allows a clean, precise cut. Piezoelectric surgery is very efficient for osteotomy because it works selectively—the soft tissues, including nerves and blood vessels, are unaffected. This represents a significant advantage over the use of a bur. In addition, the use of anti-inflammatory medications is the prevalent attitude to decrease postoperative complications. Corticosteroids are one of the most widely employed medications administered to control these complications. Dexamethasone is known to be more powerful than other anti-inflammatory drugs because of its extended duration of action. The rationale of this study is to see if there a difference in post operative sequelae using Piezo-surgery, Piezo-surgery with submucosal Dexamethasone, Piezo-surgery with surgical drain after the extraction of impacted mandibular third molars.



 
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