FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047476 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 24/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Checking the pain relief and wound healing property of homeopathic medicine after tooth removal  
Scientific Title of Study   “Evaluating the analgesic and wound healing efficacy of Arnica Montana after tooth extraction – A Cross over mouth split study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anudarsh PK 
Designation  Postgraduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Coorg Institute of Dental SCiences, Virajpet, Coorg
Maggula, Virajpet, Coorg
Kodagu
KARNATAKA
571218
India 
Phone  9361413518  
Fax    
Email  itsmedarsh25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anudarsh PK 
Designation  Postgraduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Coorg Institute of Dental SCiences, Virajpet, Coorg
Maggula, Virajpet, Coorg

KARNATAKA
571218
India 
Phone  9361413518  
Fax    
Email  itsmedarsh25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anudarsh PK 
Designation  Postgraduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Coorg Institute of Dental SCiences, Virajpet, Coorg
Maggula, Virajpet, Coorg

KARNATAKA
571218
India 
Phone  9361413518  
Fax    
Email  itsmedarsh25@gmail.com  
 
Source of Monetary or Material Support  
COORG INSTITUTE OF DENTAL SCIENCES 
 
Primary Sponsor  
Name  Dr Anudarsh PK 
Address  DEPARTMENT OF PUBLIC HEALTH DENTISTRY, COORG INSTITUTE OF DENTAL SCIENCES, MAGGULA, VIRAJPET, COORG, KARNATAKA 
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 JITHESH JAIN  COORG INSTITUTE OF DENTAL SCIENCES  Department of Public Health Dentistry
Kodagu
KARNATAKA 
9448706263

drjitheshjain@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Coorg Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K053||Chronic periodontitis, (3) ICD-10 Condition: K027||Dental root caries, (4) ICD-10 Condition: K006||Disturbances in tooth eruption,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arnica Montana 200C globules  After the extraction of tooth, Arnica Montana 200C globules will be given to the patients. Patients will be advised to take 4 globules qid for 3 days. 
Comparator Agent  Tablet Paracetamol 500 mg  After the extraction of tooth, Paracetamol 500mg tablets will be given to the patients. Patients will be advised to take 1 tablet t.i.d for 3 days. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Individuals who are willing to participate in the study.
2)Individuals who needs extraction of teeth in the opposite quadrants. 
 
ExclusionCriteria 
Details  1)Individuals with severe dental infection.
2)Individuals who are in antibiotic treatment
3)Individuals with uncontrolled diabetes
4)Individuals with any bleeding or clotting disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A 4-point verbal rating scale (VRS) questionnaire will be used for the assessment of pain.  IT WILL BE CHECKED AT THE 3RD AND 7TH DAY AFTER EXTRACTION OF EACH TOOTH. 
 
Secondary Outcome  
Outcome  TimePoints 
Wound healing, will be assessed by evaluating the extracted site for signs of normal healing alveolus, acutely inflamed alveolus, acutely infected alveolus, alveolar osteitis.  IT WILL BE CHECKED AT THE 3RD DAY AND 7TH DAY AFTER THE EXTRACTION OF EACH TOOTH. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   25/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study participants will be selected from patients visiting the Coorg Institute of Dental sciences. 15 – 60 years old Patients who need extraction of teeth in the opposite sides/quadrants of the mouth will be included in the study. The total sample size of 24 will be divided equally and assigned  into two groups namely Group A and Group B. In Group A, participants will be advised to take Arnica Montana 200C globules after first extraction and tablet paracetamol 500 mg after the second extraction in the opposite side of the mouth. In Group B, participants will be advised to take tablet Paracetamol 500 mg after the first extraction and 200C Arnica Montana after the second extraction. Prior to start of procedures written consent will be obtained from the participants. The extracted site will be evaluated on the 3rd and 7th day postoperatively for assessment of pain and wound healing. Second extraction in the opposite side of the mouth will be done after 7 days from the first extraction. The extracted site will be evaluated on the 3rd and 7th day postoperatively for assessment of pain and wound healing. Pain will be assessed using 4-point verbal rating scale and wound healing will be assessed by examining the extracted site for signs of normal healing alveolus, acutely inflamed alveolus, acutely infected alveolus, alveolar osteitis.

 
Close