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CTRI Number  CTRI/2020/04/024891 [Registered on: 28/04/2020] Trial Registered Prospectively
Last Modified On: 22/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Other 
Public Title of Study   Role of intravenous anti-oedema drug in "piezo-assissted" extraction of third molar. 
Scientific Title of Study   Influence of intra-venous Dexamethasone in controlling post-operative complications in piezo-assissted third molar surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anand Deep Shukla 
Designation  Assistant Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No.4, Department of OMFS, MCODS, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9742354052  
Fax    
Email  anand.shukla@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Anand Deep Shukla 
Designation  Assistant Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No.4, Department of OMFS, MCODS, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9742354052  
Fax    
Email  anand.shukla@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Anand Deep Shukla 
Designation  Assistant Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No.4, Department of OMFS, MCODS, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9742354052  
Fax    
Email  anand.shukla@manipal.edu  
 
Source of Monetary or Material Support  
Room No.4, Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Udupi, Karnataka-576104. 
 
Primary Sponsor  
Name  Rahul Mukul Chaubey 
Address  Room No.4, Department of OMFS, MCODS, Manipal. 
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 
Rahul Mukul Chaubey  Manipal College of Dental Sciences, Manipal  Room No.4, Department of OMFS, MCODS, Manipal.
Udupi
KARNATAKA 		 8888822998

chaubey27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients who are diagnosed with partially or unerupted third molar requiring "piezo-assissted" surgical dental extraction. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparing the effect of intra-venous dexamethasone in piezo-assisted third molar extraction.   Comparing the effect of intra-venous dexamethasone in influencing pain, swelling and mouth opening (trismus) in piezo-assisted third molar extraction. One dose of 4mg intra-venous dexamethasone will be administered for the third molar extraction surgery which usually takes 30-45 minutes for completion. 
Intervention  Injecting intra-venous dexamethasone in piezo-assisted third molar extraction.   Comparing the effect of intra-venous dexamethasone in influencing pain, swelling and mouth opening (trismus) in piezo-assisted third molar extraction. One dose of 4mg intra-venous dexamethasone will be administered for the third molar extraction surgery which usually takes 30-45 minutes for completion.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients who are willing to participate in the study.
2) Patients above 18 years of age.
3) Pederson difficulty index 3-5.
4) ASA 1 (American society of Anaesthesiologists)/ASA 2 patients. 
 
ExclusionCriteria 
Details  1) Patients on cardiac pacemakers.
2) Patients with systemic disease and drug allergy.
3) Patients with acute infection at the time of surgery such as pericoronitis, acute alveolar abscess.
4) Patients with dense sclerotic bone disease. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain, oedema and mouth opening/trismus post-operatively after impacted third molar surgery with piezoelectric device with or without intra-venous dexamethasone.  At the end of the study. 
 
Secondary Outcome  
Outcome  TimePoints 
The study will help in understanding the effect of intra-venous dexamethasone and help in better planning of third molar extractions.  At the end of the study. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   01/05/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Title of the study : Influence of intra-venous Dexamethasone in controlling post-operative complications in piezo-assisted third molar surgery.

Type of study : Prospective, Interventional.

Study period : 18 months ( 1 year and 6 months)

Aim of the study : To assess wheather administration of intra-venous dexamesthasone is instrumental to reduce post-operative complications following piezo-assisted third molar surgery.

Objectives of the study : 

1) To administer intra-venous dexamethasone in test group of patients undergoing piezo-assisted third molar surgery.
2) To compare post-operative pain using VAS scale in both test and control group of patients.
3) To compare mouth opening/trismus using vernier caliper in both test and control group of patients.
4) To assess wheather piezo-assisted third molar surgeries require intra-venous dexamethasone to control post-operative complications.

Sample size : 60 patients above 18 years of age, divided into 2 groups based on block method of randomization (ABAB, AABB, ABBA, BABA, BBAA)

Group 1 :  30 patients (piezo-assisted impacted third molar surgery)
Group 2 : 30 patients  (piezo-assisted impacted third molar surgery + Injection dexamethasone)

Detailed description of the procedure : 

The study will be conducted in the Department of Oral and Maxillofacial Surgery, MCODS, Manipal. A detailed written informed consent will be obtained from each patient. Patients will be asked to rinse the oral cavity with 2% povidine-iodine solution 5 minutes prior to the procedure. All procedures will be performed by a single surgeon under local anaesthesia blockade of an inferior alveolar nerve (IAN), lingual and long buccal nerve block using 2% lidocaine hydrochloride with 1:200000 adrenaline. A modified wards’s incision with distal extension will be placed and full thickness mucoperiosteal flap will be reflected to expose the impacted teeth and surrounding bone. Following this piezosurgical unit and bone cutting piezo tips ( ACETON) and tooth cutting ninja tips (ACETON) will be used for carrying out trans-alveolar extraction of third molar. The wound closure will be achieved by placing using 3-0 black braided silk sutures. In group 2, post-operatively, all the patients will be administered injection. Dexamethasone 4mg. The post-operative follow-up will be scheduled on 1st, 3rd and 7th day. We will compare these parameters : 

1)  To compare post-operative pain using VAS scale in both test and control group of patients.
2) To  compare swelling using facial measurements in both test and control group of patients.
3) To compare mouth opening/trismus using vernier caliper in both test and control group of patients.

Potential risks : Patients will be required to spend time during the pre-operative and post-operative follow up period. Chances of pain / oedema / trismus following impacted lower third molar removal.

Potential benefits : In clinical practice, piezo surgery plays an important role in reducing post-operative pain, trismus and also swelling. Supplementation with injection dexamesthasone will enhance its post-operative complications reducing effect.

Budget : Self-funded (Not applicable)

Ethical considerations and method to address issues : Ethical committee clearance and CTRI approval shall be taken prior to initiation of the study.

Compensation : Storage and maintenance of all trial database will be done for a period of 3 years. Reporting of adverse events  will be done to Institutional Ethics Committee, Kasturba Hospital, Manipal. No compensation will be given to be a part of the study, however, compensation will be given in case of any adverse events/ injury during the period of the study by principal investigator. The study does not have any conflict of interest.
 
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