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CTRI Number  CTRI/2024/11/076252 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effectiveness of Irimedadi Oil and Arginine Toothpaste in Reducing Tooth Sensitivity: A Clinical Trial 
Scientific Title of Study   Efficacy of Irimedadi oil compared to 8 percentage arginine toothpaste as a desensitizing agent - 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 Jishnu Pradeep 
Designation  Post-Graduate Student  
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8848177180  
Fax    
Email  drjishnupradeep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishu Singla 
Designation  Associate Professor  
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9965404403  
Fax    
Email  nishu.singla@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Jishnu Pradeep 
Designation  Post-Graduate Student 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8848177180  
Fax    
Email  drjishnupradeep@gmail.com  
 
Source of Monetary or Material Support  
MCODS, Room no 8, Department of Public Health Dentistry, Manipal College of Dental Science, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104  
 
Primary Sponsor  
Name  Dr JISHNU PRADEEP  
Address  Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104  
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aneesh E G  Manipal Academy of Higher Education  Division of Ayurveda, Centre for Integrated Medicine and Research, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA 
9645716972

aneesh.eg@manipal.edu 
Dr Jishnu Pradeep  Manipal College of Dental Sciences, Manipal  Room No :8, Department of Public Health Dentistry, 2nd Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA 
8848177180

drjishnupradeep@gmail.com 
Dr Jishnu Pradeep  Manipal College of Dental Sciences, Manipal  Room No :1, Department of Oral Medicine and Radiology, Ground Floor, Manipal College of Dental Sciences, Manipal, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA 
8848177180

drjishnupradeep@gmail.com 
 
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:K030||Excessive attrition of teeth. Ayurveda Condition: DANTAHARSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Irimedadi Oil, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 1(drops), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 1 Months, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator Arm (Non Ayurveda)-Colgate Sensitive Pro-relief ToothpasteDesensitizing Toothpaste is to be used twice a day for 1 month
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a) Subjects presenting complaints of dentinal hypersensitivity which may be due to attrition,
erosion, gingival recession, and root exposure or unrestorable cervical abrasion lesions.
b) Subjects who are 18 years and above.
c) Subjects having a minimum of one tooth with dentinal hypersensitivity.  
 
ExclusionCriteria 
Details  a) Subjects not willing to participate.
b) Subjects with complaints of sensitivity due to caries, deep abrasions requiring class V
restorations, chipped teeth, and fractured cusps.
c) Subjects using any type of desensitizing therapy from the last 6 months.
d) Subjects with a history of chronic use of analgesics or anti-inflammatory drugs, pregnant or
lactating females, and those with any denture or bridgework that would interfere in the
evaluation of hypersensitivity.
e) Subjects who use any dental aids other than toothbrushes and toothpaste to clean their teeth.
f) Subjects with dentinal hypersensitivity in which restorations can be suggested as a treatment
plan. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Dentinal Hypersensitivity  Baseline
10 days
21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in gingivitis  Follow up at 10 days & 21 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/11/2024 
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="1"
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  

Dentinal hypersensitivity, caused by exposed dentinal tubules due to enamel or cementum wear, significantly affects patients’ daily lives by causing pain that disrupts sleep, work, and dietary habits. While self-applied desensitizing toothpastes like Colgate Sensitive Pro-relief, which contains 8% arginine, are commonly used, their primary disadvantage is the time needed for symptom relief. Irimedadi Oil, an Ayurvedic preparation with astringent, antimicrobial, and anti-inflammatory properties, is effective against various oral conditions, including dentinal hypersensitivity. A study reported that 26% of patients experienced relief after 10 days of using Irimedadi Oil, increasing to 76% after 21 days. If found effective, Irimedadi oil would be a natural, organic, herbal alternative for hypersensitivity patients.   

A Randomized controlled trial will be conducted to evaluate the effectiveness of Irimedadi Oil against Colgate Sensitive Pro-relief in patients with dental hypersensitivity. Patients from a dental outpatient department will be selected based on specific inclusion and exclusion criteria. A pilot study with 25 patients in both groups will be conducted for 10 days. This will help determine the sample size for a 21-day trial.

In the study, 50 subjects will be randomly divided into two groups using by block randomization method, with one group receiving Irimedadi Oil and the other Colgate Sensitive Pro-relief.

A Double-blinded methodology will be followed in which the investigator and the analyzer will be blinded as the agents will be distributed in prenumbered concealed containers.

Baseline tactile, air blast, and cold sensitivity assessments will be conducted using established pain and sensitivity scales. Participants will follow specific application instructions for the oil or toothpaste and be asked to use non-fluoridated toothpaste for regular brushing. Follow-ups will be scheduled after 10 and 21 days to reassess sensitivity using the same tests.

 
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