| CTRI Number |
CTRI/2026/03/105561 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess and compare pain perception and efficacy on topical application of 20% benzocaine gel and a vibratory stimulus during local anesthesia administration in pediatric dental patients |
|
Scientific Title of Study
|
Comparative evaluation of pain perception on topical application of 20 percent benzocaine gel and a vibratory stimulus during local anesthesia administration in pediatric patients: a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GTBHEC 2025/P-233 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
amit khatri |
| Designation |
professor (SAG) |
| Affiliation |
UCMS and GTBH, dilshad garden |
| Address |
room no. 253, gtb hospital, second floor opd building, gtb hospital, Dilshad Garden
East
DELHI
110095
India |
| Phone |
9999954120 |
| Fax |
|
| Email |
khatri9804@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
amit khatri |
| Designation |
professor (SAG) |
| Affiliation |
UCMS and GTBH, dilshad garden |
| Address |
room no. 253, gtb hospital, second floor opd building, gtb hospital, Dilshad Garden
DELHI
110095
India |
| Phone |
9999954120 |
| Fax |
|
| Email |
khatri9804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
amit khatri |
| Designation |
professor (SAG) |
| Affiliation |
UCMS and GTBH, dilshad garden |
| Address |
room no. 253, gtb hospital, second floor opd building, gtb hospital, Dilshad Garden
DELHI
110095
India |
| Phone |
9999954120 |
| Fax |
|
| Email |
khatri9804@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amit Khatri |
| Address |
Room no. 253, OPD building, second floor, GTB hospital, New Delhi 110095 |
| 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 AMIT KHATRI |
GTB HOSPITAL |
ROOM NUMBER 250, DENTAL DEPARTMENT, SECOND FLOOR OPD BUILDING, UCMS AND GTB HOSPITAL, DILSHAD GARDEN, 110095
East
DELHI |
9999954120
khatri9804@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GURU TEG BAHADUE HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
20% benzocaine gel with 2% lignocaine injection |
20% benzocaine gel applied topically followed by 2% lignocaine injection applied during extraction |
| Comparator Agent |
Vibratory stimulus with 2% lignocaine injection |
Vibratory stimulus applied intraorally at the site of injection followed by 2% lignocaine injection applied during extraction |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1. Children in age range of 7 to 10 years of both genders.
2. Patients with Frankls behaviour rating scale positive or definitely positive.
3. Children requiring extraction of any mandibular primary molar.
4. Children belonging to ASA Category One and having no history of allergy to local anesthetic solutions.
5. Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Children with specific medical illness or physiological impairment.
2. Children with known allergy to local anesthesia.
3. Patients with Frankls behaviour rating scale negative or definitely negative.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess and compare efficacy of 20% benzocaine gel and a vibratory stimulus on pain caused during administration of local anaesthesia in children. |
during administration of local anaesthesia in children. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess and compare efficacy of 20% benzocaine gel and a vibratory stimulus on anxiety using an objective scale and physiological parameters at various time points. |
before and after treatment |
| 2. To evaluate the acceptability of each technique used, as assessed by parents. |
after treatment |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
28/04/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients will be recruited from the outpatient setting of Department of Dentistry (Unit of Pediatric and Preventive Dentistry), University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi. A total of 42 systemically healthy subjects in the age group of 7-10 years requiring dental treatment in the mandibular arch which includes the administration of inferior alveolar nerve block will be included in the study. After satisfying the inclusion and exclusion criteria, subjects will be randomly assigned to one of the two groups using computer-generated random table. Groups | Intervention | Sample Size | I | 20% benzocaine gel with 2% lignocaine injection | 21 | II | Vibratory stimulus with 2% lignocaine injection | 21 |
|