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CTRI Number  CTRI/2025/08/092346 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 03/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing how well three different treatments work in reducing pain, swelling, and discomfort after wisdom tooth removal: cold saline rinses, regular saline rinses combined with oral enzyme tablets, and regular saline rinses combined with an anti-inflammatory injection under the gum. 
Scientific Title of Study   COMPARISON OF EFFICACY OF COLD SALINE IRRIGATION, NORMAL SALINE IRRIGATION WITH ORAL ENZYME PREPARATION AND NORMAL SALINE IRRIGATION WITH SUBMUCOSAL DEXAMETHASONE INFILTRATION ON POST OPERATIVE SYMPTOMS AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR - 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  Rishabh Yadav 
Designation  Post graduate student 
Affiliation  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI 
Address  Room Number 5 Department of Oral and Maxillofacial Surgery KLE VK Institute of Dental Sciences JNMC campus Nehru Nagar Belagavi
JNMC CAMPUS , NEHRU NAGAR BELAGAVI .
Belgaum
KARNATAKA
590010
India 
Phone  9967970913  
Fax    
Email  rishaby14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rishabh Yadav 
Designation  Post graduate student 
Affiliation  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI 
Address  Room Number 5 Department of Oral and Maxillofacial Surgery KLE VK Institute of Dental Sciences JNMC Campus Nehru Nagar Belagavi
JNMC CAMPUS , NEHRU NAGAR , BELAGAVI.
Belgaum
KARNATAKA
590010
India 
Phone  9967970913  
Fax    
Email  rishaby14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SD Baliga 
Designation  Professor 
Affiliation  KLE VK Institute of Dental Sciences 
Address  Room Number 5 Department of oral and maxillofacial Surgery KAHERS KLE VK Institute of Dental Sciences Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9341102665  
Fax    
Email  baliga1974@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Sciences , BELAGAVI 590010 , KARNATAKA , INDIA. 
 
Primary Sponsor  
Name  Rishabh Yadav 
Address  Room Number 5 Department of Oral and Maxillofacial Surgery KLE VK Institute of Dental Sciences JNMC Campus Nehru Nagar Belagavi 
Type of Sponsor  Other [self funding] 
 
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 Rishabh Yadav  KAHERS KLE VK Institute of Dental Sciences  Room Number 5 Department of oral and maxillofacial surgery KLE VK Institute of Dental Sciences JNMC Campus Nehru Nagar Belagavi
Belgaum
KARNATAKA 
9967970913

rishaby14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Impacted tooth cases 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Normal Saline Irrigation With Oral Enzyme Preparation  Irrigation of Extraction Socket with Normal Saline Followed by Prescribing Oral Enzyme Preparation After Closure of Extraction Socket. 
Comparator Agent  Normal Saline Irrigation with Submucosal Dexamethasone Infiltration  Extraction Socket will be Irrigated with Normal Saline followed by Infiltration with Dexamethasone Submucosally. 
Intervention  Cold Saline  Extraction Socket will be Irrigated with Cold Saline having a Temperature of 2-8 Degrees Centigrade. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) pt belonging to the age group of 18-40 years .
2) pt who have not used any antibiotic, anti-inflammatory 1 week before the surgery
3)pt with mild to moderate surgical difficulty on evaluation according to Pederson difficulty index score 3-4 and 5-7
4) pt with normal bleeding and clotting time
5) pt who are non smokers
6)pt with ASA 1 category
7) pt having indication for extraction of impacted mandibular third molar 
 
ExclusionCriteria 
Details  1) pt who are not willing to participate or take part in the study.
2) pt with previous allergies to anaesthetic agents used.
3) pregnant or lactating female patients.
4) pt who are immunocompromised or suffering from any systemic conditions.
5)pt having bacterial and fungal infection
6) pt allergic to corticosteroids.
7) pt on anticoagulant drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative swelling  3rd and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain  3rd & 7th day 
Post operative trismus  3rd & 7th day 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/08/2025 
Date of Study Completion (India) 05/11/2025 
Date of First Enrollment (Global)  15/08/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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   Third molar surgical removal is one of the most common procedures performed by Oral & Maxillofacial surgeons, it is often associated with post operative swelling, pain and trismus which are inflammatory signs and symptoms that cause discomfort and also can have an impact on quality of life

To reduce post operative discomfort, different pharmacological managements have been proposed by various authors;

Normal saline is commonly used as a irrigating solution in third molar surgeries as it decreases the heat generated by surgical drill while contacting bone thus reducing the chance of inflammation and tissue damage
In some studies, surgeons prefer cold saline irrigation  (2-8 degree celsius) and they believe that it is more effective than normal saline irrigation.

Corticosteroids have been used most frequently for post operative management after 3rd molar surgeries, dexamethasone is most commonly used for post operative swelling , pain and trismus the conventional route for dexamethasone drug delivery is through intramuscular and intravenous route ,however these techniques require additional clinical skills and may not be as pleasant to the conscious patient as well.

As an alternative submucosal injection (SM) has been reported to be an effective , convenient and straightforward way of administering dexamethasone
 
Nonsteroidal Anti-inflammatory drugs have often been prescribed to reduce post operative inflammatory complications caused by third molar surgery, however the side effects associated are numerous primarily gastro intestinal, renal disorders , propensity to cause skin and mucosal reactions.

Hence a natural, effective, and safe remedy that lacks undesirable side effects would offer a better alternative treatment

Bromelain is a proteolytic enzyme derived from stem of pineapple plant( Ananas Comosus) and presents anti-inflammatory anti edemic and anti fibrinolytic  properties , which can be beneficial in post operative management after 3rd molar surgery. 

 
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