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CTRI Number  CTRI/2024/06/068518 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two types of injection on pain, restricted mouth opening and swelling after removal of unerupted lower wisdom teeth 
Scientific Title of Study   The efficacy of sublingual and intravenous injection of dexamethasone on pain, trismus and swelling after surgical removal of impacted mandibular third molars: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sreelekshmi J 
Designation  Post Graduate Student 
Affiliation  KVG Dental College and Hospital 
Address  Room No:2 Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital Kurunjibhag, Sullia D K Karnataka

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8281104947  
Fax    
Email  dr.sreelekshmijayasree@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanna Kumar D 
Designation  Professor and Head of Department 
Affiliation  KVG Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital, Kurunjibhag, Sullia D K Karnataka

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448177525  
Fax    
Email  dr_prasanna_74@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanna Kumar D 
Designation  Professor and Head of Department 
Affiliation  KVG Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital, Kurunjibhag, Sullia D K Karnataka

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448177525  
Fax    
Email  dr_prasanna_74@yahoo.co.in  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka Pincode - 574327 
 
Primary Sponsor  
Name  Dr. Sreelekshmi J 
Address  KVG Dental College and Hospital, Kurunjibhag, Sullia D K, Karnataka-574327 
Type of Sponsor  Other [SELF] 
 
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 Sreelekshmi J  KVG Dental College and Hospital  Department of Oral and Maxillofacial Surgery KVG Dental College and Hospital Kurunjibhag Sullia D K
Dakshina Kannada
KARNATAKA 
8281104947

dr.sreelekshmijayasree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Impacted mandibular third molars which requires surgical removal by the guttering method. 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone  Intravenous injection of 2ml Dexamethasone preoperatively within a time duration of 2 minutes 
Intervention  Dexamethasone  Sublingual injection of 2ml Dexamethasone preoperatively within a time duration of 2 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients with impacted lower third molars symmetrically placed on mandible, which requires surgical removal by flap reflection, bone guttering and tooth sectioning.
Healthy patients (ASA I).
Patients who are willing to take part in study. 
 
ExclusionCriteria 
Details  1.Patients on long-term steroids.
2.Pregnant and lactating women.
3.Patients with acute infection and trismus.
4.Patient allergic to local anesthetics and other drugs that will be used in this study.
5.Patient with facial deformities that may hinder injections, surgery or evaluation.
6.Patients with cardiovascular problems, renal and/or liver failure, or other severe medical conditions.
7.Not being able to follow instructions or cooperate during study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The efficacy of dexamethasone administration through intravenous and sublingual routes on pain using VAS scale, Swelling using Schultze-Mosgau method and mouth opening by interincisal measurement in impacted mandibular third molar surgeries   Postoperative day 1,2,3 and 7 
 
Secondary Outcome  
Outcome  TimePoints 
Any effect on quality of life  1 week 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   17/06/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Various methods of administering dexamethasone in third molar surgery have been proposed. Intravenous (IV) injection requires additional clinical expertise, and administering IV dexamethasone in conscious patients may lead to transient perineal irritation (itching, burning, or squeezing sensation) in some individuals. Additionally, a single IV injection of dexamethasone can spread widely throughout the body, potentially resulting in less than optimal effectiveness at the injury site.

The sublingual route has advantage of not causing additional postoperative pain for patients when administered following common dental interventions like the inferior alveolar nerve block, lingual nerve block and long buccal nerve block typically performed in mandibular third molar procedures. This method is straightforward and easily manageable for dentists.

In present study, the effectiveness of dexamethasone administered via sublingual versus intravenous routes will be assessed, the outcome of this study will help the dental surgeons to choose the appropriate route of administration of dexamethasone.

Under strict aseptic conditions, patients will be prepared for the surgical procedure. A classical inferior alveolar nerve block, along with lingual and long buccal nerve block will be administered. After 5 minutes, patients in Group A will receive 8 mg dexamethasone intravenously injected into either the median cubital or radial vein, whereas, patients in Group B will receive 8 mg injection dexamethasone into sublingual space. Time taken to administer dexamethasone through both the routes will be noted using timer. Utilizing a standard Ward’s incision, access will be gained, and the tooth will be extracted after necessary bone cutting and tooth splitting, ensuring minimal tissue trauma.  Post-extraction, the socket will be thoroughly irrigated with a 5% povidone-iodine solution diluted with equal proportion of normal saline. The flap will then be sutured back using two interrupted sutures of 3-0 BBS (Black Braided Silk). Follow-up appointments will be scheduled for all patients on first,second,third and seventh postoperative days. Suture removal will be carried out on the seventh postoperative day if the healing is assessed to be satisfactory.

 
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