| CTRI Number |
CTRI/2025/07/090900 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Aloe Vera Gel and Recaldent™ for Reducing Tooth Sensitivity in patients having Dentinal hypersensitivity |
|
Scientific Title of Study
|
Comparative evaluation of clinical effectiveness of 80% Aloe vera gel and Recaldent™ by topical application in management of dentinal hypersensitivity An experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal Eknath Gaikar |
| Designation |
Student |
| Affiliation |
SMBT Institute of Dental Science and Research |
| Address |
SMBT Institute of Dental Science and Research,Nandi hills, Dhamangaon, Igatpuri,Dist Nashik.Department of Conservative Dentistry and Endodontics Room no.201
Nashik
MAHARASHTRA
422403
India |
| Phone |
9881309684 |
| Fax |
|
| Email |
komalresearch33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Bohora |
| Designation |
Professor and Pg guide |
| Affiliation |
SMBT Institute of Dental Science and Research |
| Address |
SMBT Institute of Dental Science and Research,Nandi hills, Dhamangaon, Igatpuri,Dist Nashik.Department of Conservative Dentistry and Endodontics Room no.201
Nashik
MAHARASHTRA
422403
India |
| Phone |
7020054267 |
| Fax |
|
| Email |
draab.endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Komal Eknath Gaikar |
| Designation |
Student |
| Affiliation |
SMBT Institute of Dental Science and Research |
| Address |
SMBT Institute of Dental Science and Research,Nandi hills, Dhamangaon, Igatpuri,Dist Nashik.Department of Conservative Dentistry and Endodontics Room no.201
Nashik
MAHARASHTRA
422403
India |
| Phone |
9881309684 |
| Fax |
|
| Email |
komalresearch33@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Institute of Dental Science and Research, Nandi hills, Dhamangaon, Igatpuri, Nashik, Maharashtra 422403,India |
|
|
Primary Sponsor
|
| Name |
Komal Eknath Gaikar |
| Address |
SMBT IDSR,Nandi hills, Dhamangaon, Igatpuri, Nashik, Maharashtra 422403 , India |
| 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 |
| Komal Eknath Gaikar |
SMBT Institute of Dental Science and Research |
SMBT Institute of Dental Science and Research,Nandi hills, Dhamangaon, Igatpuri,Dist Nashik 422403.Department of Conservative Dentistry and Endodontics Room no. 201
Nashik
MAHARASHTRA |
9881309684
komalresearch33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT IDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
80% Aloevera gel |
Topical application of 80% Aloevera gel once a week for treatment period of three weeks for managing dentinal hypersensitivity |
| Comparator Agent |
Recaldent™ |
Topical application of Recaldent™ once a week for treatment period of three weeks for managing dentinal hypersensitivity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 and 50 years of age visiting SMBT IDSR, Nashik for treatment of dentinal hypersensitivity. |
|
| ExclusionCriteria |
| Details |
Patient with history of any systemic illness or psychological conditions and previous hospitalization.
Participants who are unwilling or unable to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of 80% Aloevera gel in managing dentinal hypersensitivity |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Herbal agent over allopathic agent in reducing dentinal hypersensitivity |
1 week,2 weeks,3 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/07/2025 |
| 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="1"
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
|
Informed consent will be obtained from the patients A sample consisted of 26 patients with 52 teeth with DH who had fulfilled the selection criteria All the teeth were divided into two groups Group A 80% Aloevera gel Group B Recaldent The desensitizing agents will be applied by a trained and experienced operator on days 1st 7th 14th and 21st days of month Removal of debris and calculus if any around the affected teeth using hand scalers and Isolation of the teeth with cotton rolls
Aloevera gel is applied directly on the DH site using a applicator tip and let dried for 60 s Recaldent™ was applied to the sensitive lesions as recommended by the manufacturer The patients were instructed not to rinse or eat or drink anything for 30 min after the treatment and avoid using any other professionally or self applied desensitizing agent in the course of the investigation
Each tooth received two stimuli Clinical probing and Air blast
The degree of hypersensitivity reported by the participant with each stimulus was determined according to the verbal rating scale from 0 to 3 in which 0 represent No discomfort 1 represent Minimum discomfort 2 represent Mild discomfort 3 represent Intense discomfort
The values were collected before the intervention and after each application, on days 1st 7th 14th and 21st respectively The spilt mouth technique was used to obtain the standardized response from each patient for all two treatment groups
The collected data will be tabulated and subjected to statistical analysis |