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
|
|
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
|
|
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. |