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CTRI Number  CTRI/2024/01/061963 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To compare the effectiveness of cold saline wash VS steroid injection in reducing discomfort after wisdom tooth removal. 
Scientific Title of Study   Efficacy of cooled saline irrigation vs. pre-operative intravenous Dexamethasone in reducing post-operative swelling, pain and trismus after surgical removal of lower impacted third molar: A single center split mouth prospective clinical 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 Srikanth G 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  srikanth.mds@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srikanth G 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  srikanth.mds@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Srikanth G 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986455201  
Fax    
Email  srikanth.mds@manipal.edu  
 
Source of Monetary or Material Support  
Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Dr Srikanth G 
Address  Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal 
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 Srikanth G  Kasturba Medical College & Hospital  Room 4, Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal 576104
Udupi
KARNATAKA 
9986455201

srikanth.mds@manipal.edu 
 
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 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cooled saline irrigation  Cooled saline (4 degree C) will be used while bone drilling during wisdom tooth removal. No steroid injection will be administered to patients. Swelling, pain and difficulty in mouth opening will be evaluated post-operatively on day 0, day 3 and day 7 
Comparator Agent  IV Dexamethasone 8mg  IV Dexamethasone 8mg is administered to the patient 30 mins before undergoing wisdom tooth removal. Room temperature saline will be used during bone drilling. Swelling, pain and difficulty in mouth opening will be evaluated post-operatively on day 0, day 3 and day 7 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) 18 years or older healthy patients.
2) Bilateral impacted lower third molar needing extraction with the necessity of bone removal based on panoramic radiography.
3) Patients who live within 10km radius of the hospital.
4) Patients who give written consent. 
 
ExclusionCriteria 
Details  1) Less than 18 years with comorbidities.
2) Second molars with severe periodontal defect or deep periodontal pocket.
3) Cysts or tumors around the impacted third molar.
4) History of bleeding disorders, smoking, alcoholism and pregnant patients.
5) Patients who live beyond 10 km radius of the hospital.
6) Patients who do not give written consent to participate in the study and follow up. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the intensity of post-operative morbidity (pain, facial swelling, and trismus) following surgical removal of lower impacted third molar performed using cooled saline vs. single dose intravenous (IV) Dexamathasone administered pre-operatively.  1. Pre-operative (day 0)
2. Post-operative day 1
3. Post-operative day 3
4. Post-operative day 7 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/02/2024 
Date of Study Completion (India) 01/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This is a single-center split-mouth clinical trial. Patients reporting to Department of Oral and Maxillofacial Surgery, MCODS, Manipal with bilateral mandibular mesioangular or horizontal third molar teeth and satisfying all other inclusion criteria will be included in the study. Radiographic evaluation (orthopantomogram) will be done to classify the impaction and those with Class I or II, level A or B impaction will be considered.

 

For the control group (n=32), IV Dexamethasone will be administered 1 hour before the procedure in the cubital fossa. For the test group (n=32), saline bottles will be refrigerated in the department to attain a temperature of 4°C (to be confirmed with non-contact thermometer). A gap of 21 days will be ensured between procedures on either side. The operator and patient will not be blinded. However, the outcome assessor, who will be another surgeon in the department, will be blinded to the procedure. Blinding will be achieved by ensuring that the surgeon is not present in the operatory during the procedure.

 

All procedures will be carried out by the same maxillofacial surgeon in the department. The routine steps for lower third molar removal will be followed:

  • Local anaesthesia with inferior alveolar, lingual and long buccal nerve blocks (lignocaine with adrenaline 1:2,00,000).
  • Modified Ward’s incision and raising a full thickness mucoperiosteal flap.
  • Osteotomy or drilling of bone around the tooth and sectioning of tooth (702 straight carbide bur attached to a micromotor handpiece will be used). For the test side, irrigation will be carried out with cold saline at 4°C. For the control side, irrigation will be carried out with saline at room temperature.
  • After tooth removal, irrigation and curettage of the socket, Gelfoam placement and closure with simple interrupted 3-0 silk sutures will be done.
  • Placement of gauze pack at the local site for 1 hour will be advised to all patients.
  • All post-extraction instructions will be given to the patient in written format.
  • Suture removal to be done on 7th post-operative day.

 

Medications prescribed to both groups will be the same: Antibiotic (Amoxicillin 500mg + Clavulanic acid 125mg 2 times/day for 5 days), analgesic (Paracetamol 650mg 3 times/day for the first 3 days, and then SOS), and chlorhexidine mouthwash (3 times/day) after the first 24 hours.

 

The parameters that will be measured are:

  1. Facial measurement: This parameter will help us determine facial swelling. It will be measured with the help of 4 reference points on the face and a flexible scale (cm):
  • Lateral canthus of eye to gonium on the same side
  • Tragus to corner of mouth on the same side
  1. Pain: Visual analogue scale (1-100) will be used to document the level of pain the patient is feeling (1 being the least pain and 100 being the most pain)
  2. Mouth opening: The distance between the upper right and lower right central incisors will be measured with a scale (cm).

 

These parameters will be measured and documented across 4 time points:

  1. Pre-operative (POD 0)
  2. First post-operative day (POD 1)
  3. Third post-operative day (POD 3)
  4. Seventh post-operative day (POD 7)

 

Additionally, patients will be asked to record the number of additional analgesics they are taking. We will also assess and compare any inferior alveolar and/or lingual nerve injury (hypoesthesia/ paresthesia/ anaesthesia) that may have occurred on either side. This assessment will be done with the help of fine touch and two-point discrimination tests. On the 7th post-operative day, soft tissue healing will be evaluated for both the groups in terms of persistent signs of inflammation, wound dehiscence, and dry socket.

 
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