| CTRI Number |
CTRI/2026/03/105401 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a Vibration Device in Reducing Pain during Dental Injection in Children |
|
Scientific Title of Study
|
Effect of Vibration System on Pain Perception during Dental Anesthesia in children: A Randomised 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 |
PRATYAKCHA JHA |
| Designation |
III MDS |
| Affiliation |
Meenakshi Ammal Dental College and Hospital Tamilnadu |
| Address |
Room number3,department of pedodonics,Meenakshi ammal dental college and hospital,allapakkam main road
TAMIL NADU
600095
India |
| Phone |
09606371213 |
| Fax |
|
| Email |
pratyakcha.jha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JM FARZAN |
| Designation |
HOD-Department of pedodontics |
| Affiliation |
Meenakshi Ammal Dental College and Hospital Tamilnadu |
| Address |
Room number3,department of pedodonics,Meenakshi ammal dental college and hospital,allapakkam main road
TAMIL NADU
600095
India |
| Phone |
09606371213 |
| Fax |
|
| Email |
pratyakcha.jha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATYAKCHA JHA |
| Designation |
III MDS |
| Affiliation |
Meenakshi Ammal Dental College and Hospital Tamilnadu |
| Address |
Room number3,department of pedodonics,Meenakshi ammal dental college and hospital,allapakkam main road
TAMIL NADU
600095
India |
| Phone |
09606371213 |
| Fax |
|
| Email |
pratyakcha.jha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr PRATYAKCHA JHA |
| Address |
MEENAKSHI AMMAL DENTAL COLLEGE,ALLAPAKKAM MAIN ROAD,CHENNAI 600095
TAMIL NADU INDIA |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| PRATYAKCHA JHA |
MEENAKSHI AMMAL DENTAL HOSPITAL |
ROOM NUMBER 3,DEPARTMENT OF PEDODONICS,MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL,CHENNAI
Chennai
TAMIL NADU |
09606371213
pratyakcha.jha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEENAKSHI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL HEALTH |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DentalVibe vibratory system used during local anesthetic infiltration injection. |
Vibration system |
| Comparator Agent |
Topical Benzocaine gel application followed by conventional local anesthetic infiltration injection. |
Topical anesthetic gel |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
(1)Children 4 TO 9 years of age.
(2) Positive or definitely positive behavior on Frankl
scale.
(4)Children with no known history of allergies.
.(5) Parental consent for child participation in the study.
(6) Patients who are getting administered with Local Anaesthesia for the first time. |
|
| ExclusionCriteria |
| Details |
(1)Those in need of treatment under general anesthesia
(2) Children with special health care needs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study applied the gate control theory of pain modulation to determine whether large A-beta nerve fiber input from a vibration stimulus would inhibit smaller fiber A-delta and C fiber (nociceptive) input from an intraoral infiltration injection.
We expect that the amount of discomfort experienced with the use of the Dental Vibe injection comfort system during intra-oral injections would be less than traditional intra-oralinjections of local anesthetics in the adolescent patient. |
IT WILL BE ASSESSED ON WEEKLY BASIS ACCORDING TO THE CASES DONE THAT PARTICULAR WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2026 |
| 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)
|
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
|
The randomized control trial aims to evaluate the effectiveness of a vibratory dental device(Dental vibe) in reducing pain perception during administration of local anesthesia in children aged 4-9 years .A total of 42 participants will be randomly allocated into two parallel groups: a control group receiving topical benzocaine gel prior to conventional infiltration anesthesia ,and a test group receiving vibratory stimulation using Dental vibe during injection. Pain perception will be assessed using WONG BAKER FACES Pain rating scale, FLACC scale and SEM scale by both self report and external observer evaluation. Standardized injection techniques anesthetic volumes and operator consistency will be maintained. statistical analysis will be conducted using non parametric tests .the study hypothesizes that vibratory stimulation will significantly reduce pain compared with conventional topical anesthesia, based on the gate control theory of pain modulation. |