| CTRI Number |
CTRI/2025/02/080432 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of topical anesthetia on pain sensation by patient during tooth caries removal. |
|
Scientific Title of Study
|
Comparative evaluation of pain perception by patient during occlusal caries removal with and without application of topical anesthetic agent-Randomized control 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 Jui Ingole |
| Designation |
second MDS |
| Affiliation |
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli |
| Address |
department of conservative dentistry endodontics
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9307392562 |
| Fax |
|
| Email |
juiingole3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv khode |
| Designation |
associate professor |
| Affiliation |
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli |
| Address |
department of conservative dentistry endodontics
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli
Hingoli
MAHARASHTRA
431513
India |
| Phone |
8208899410 |
| Fax |
|
| Email |
rajiv.khode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jui Ingole |
| Designation |
second MDS |
| Affiliation |
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli |
| Address |
department of conservative dentistry endodontics
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9307392562 |
| Fax |
|
| Email |
juiingole3@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of conservative dentistry and endodontics dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli |
|
|
Primary Sponsor
|
| Name |
Dr jui ingole |
| Address |
Dr hedgewar smruti rugna sewa mandals dental college and hospital, hingoli |
| Type of Sponsor |
Research institution and hospital |
|
|
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 jui ingole |
Dr. Hedgewar smruti rugna sewa mandals dental college and hospital, hingoli |
department of conservative dentistry and endodontics, Dr. Hedgewar smruti rugna sewa mandals dental college and hospital, hingoli
Hingoli
MAHARASHTRA |
9307392562
juiingole3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr HSRSM dental college institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
in control group no application of topical anesthetic agent will be applied. |
benzocaine is not used in control group |
| Intervention |
TOPICAL ANESTHETIC GEL (SEPTODONT PROGEL-B)
|
effect of 20% topical anesthetic agent in gel form during cavity preparation. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patients which are not allergic to content of local anesthetic agent. |
|
| ExclusionCriteria |
| Details |
Patients allergic to contents of local anesthetic agent.
pregnant women.
lack of written or informed consent to participate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| application of 20% benzocaine gel before occlusal caries removal will be evaluated against control group that is no application for its superiority, inferiority or no effect on pain perception by patient during occlusal caries removal. |
intraoperative pain perceived by patient will be evaluated using numerical pain rating scale and visual analog scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| application of 20% benzocaine gel before occlusal caries removal will be evaluated against control group that is no application for its superiority, inferiority or no effect on pain perception by patient during occlusal caries removal. |
intraoperative pain perceived by patient will be evaluated using numerical pain rating scale & visual analog scale. source will be recorded 3 minutes after intervention during caries removal procedure. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
24/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This study is randomized control trial evaluating pain perception by patient during occlusal caries removal with and without application of topical anesthetic agent will be conducted in Dr HSRSM dental college and hospital hingoli, india. The outcome of this study will be evaluated by numeric pain rating scale and visual analog scale. |