| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K030||Excessive attrition of teeth. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: | | 2 | Comparator Arm (Non Ayurveda) | | - | Colgate Sensitive Pro-relief Toothpaste | Desensitizing 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. |