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CTRI Number  CTRI/2023/05/052189 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of lignocaine with dexmedetomidine in comparison to lignocaine with adrenaline in mandibular third molar surgery: A randomised clincial trial  
Scientific Title of Study   Efficacy of 2% lignocaine combined with dexmedetomidine in comparison with 2% lignocaine with 1:80,000 adrenaline in mandibular third molar surgery : A randomised clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jigisha Chhangani  
Designation  Post graduate student  
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Room no. 02, Oral And Maxillofacial Surgery Department, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon, Chhattisgarh. 491441 India

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9970331378  
Fax    
Email  dr.jigishachhangani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajdeep Singh  
Designation  Head of the Department  
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Room no. 02, Oral And Maxillofacial Surgery Department, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon, Chhattisgarh. 491441 India

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7587101121  
Fax    
Email  rajdeepsinghdurg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajdeep Singh  
Designation  Head of the Department  
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Room no. 02, Oral And Maxillofacial Surgery Department, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon, Chhattisgarh. 491441 India

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7587101121  
Fax    
Email  rajdeepsinghdurg@gmail.com  
 
Source of Monetary or Material Support  
Chhattisgarh Dental College and Research Institute 
 
Primary Sponsor  
Name  Chhattisgarh Dental College and Research Institute 
Address  Chhattisgarh Dental College and Research Institute, Rajnandgaon. 
Type of Sponsor  Research institution and hospital 
 
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 
Jigisha Chhangani  Department of Oral and Maxillofacial Surgery, Chhattisgarh Dental College and Research Institute  Room no. 02, Oral And Maxillofacial Department, Chhattisgarh Dental College And Research Institute, Rajnandgaon, Chhattisgarh
Rajnandgaon
CHHATTISGARH 		 9970331378

dr.jigishachhangani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
Intervention  Dexmedetomidine combined with lignocaine  5mcg/ml, that is 12.5 mcg or 0.25 ml of dexmedetomidine will be combined with 3 ml of 2% lignocaine hydrochloride as a local anesthetic. Route of administration is through inferior alveolar, lingual and long buccal nerve block. The block will be given once. 
Comparator Agent  Lignocaine with adrenaline   3 ml Standard 2% lignocaine with 1:80,000 adrenaline as a local anesthetic. The drug will be administered through inferior alveolar, lingual and long buccal nerve block. The injection will be given once. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. ASA I (Healthy patients)
2. Patients with Pederson’s difficulty index score 5-6 (moderately difficult)
3. Patients willing for third molar extraction and participating in the study 
 
ExclusionCriteria 
Details  1. Impacted third molars associated with acute infections or pathologies.
2. Pregnant and lactating females and patients on oral contraceptives.
3. Medically compromised patients (hypertension, bradycardia, hypotension, sinus disorder, liver disorders, renal impairment and uncontrolled diabetes)
4. Tobacco chewers and smokers.
5. Patients allergic to lignocaine with dexmedetomidine, lignocaine, and adrenaline 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of dexmedetomidine combined with 2% lignocaine on:
Onset of Anesthesia
Duration of Anesthesia
Pain
Edema
Mouth Opening 		 24 hours, 72 hours, 120 hours, 168 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of 2% lignocaine combined with dexmedetomidine to 2% lignocaine with 1:80,000 adrenaline  24 hours, 72 hours, 120 hours, 168 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/05/2023 
Date of Study Completion (India) 14/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/01/2024 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.jigishachhangani@gmail.com].

  6. For how long will this data be available start date provided 30-08-2022 and end date provided 01-08-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Title: EFFICACY OF 2% LIGNOCAINE WITHDEXMEDETOMIDINE IN COMPARISON TO2% LIGNOCAINE WITH 1:80,000 ADRENALINE IN MANDIBULAR THIRD MOLAR SURGERY: A RANDOMISED CLINICAL TRIAL

Aim: The aim of the study is to compare the efficacy of 2% plain lignocaine combined with dexmedetomidine and 2% lignocaine with 1:80,000 adrenaline for the removal of mandibular impacted third molars.

Objective: The objective of this study is to assess the efficacy of 2% lignocaine combined with dexmedetomidine in comparison to 2% lignocaine with adrenaline for impacted mandibular third molar surgery with regards to following parameters:
 Onset of anaesthesia
 Duration of anaesthesia
 Post-operative pain
 Oedema
 Trismus
 
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