CTRI

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CTRI Number

CTRI/2026/03/106372 [Registered on: 17/03/2026] Trial Registered Prospectively

Last Modified On:

08/06/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study comparing two devices that produce vibration and cooling to reduce pain during dental injection in children

Scientific Title of Study

Comparative evaluation of the effect of Modified V-Pen and Vibracool device on pain perception during Inferior alveolar nerve block procedure in children : 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 Lakshmi Mounica Yerubandi
Designation	Post graduate
Affiliation	GITAM Dental College and Hospital
Address	1st floor Room No 3 Department of Pediatric and Preventive Dentistry GITAM Dental College and Hospital Gandhinagar Campus Rushikonda Visakhapatnam Visakhapatnam ANDHRA PRADESH 530045 India
Phone	9398137167
Fax
Email	ylmounica99@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Jayalakshmi Pandranki
Designation	Professor
Affiliation	GITAM Dental College and Hospital
Address	1st floor Room No 3 Department of Pediatric and Preventive Dentistry GITAM Dental College and Hospital Gandhinagar Campus Rushikonda Visakhapatnam Visakhapatnam ANDHRA PRADESH 530045 India
Phone	9912860194
Fax
Email	mds.deepthi@gmail.com

Details of Contact Person
Public Query

Name	Dr Jayalakshmi Pandranki
Designation	Professor
Affiliation	GITAM Dental College and Hospital
Address	1st floor Room No 3 Department of Pediatric and Preventive Dentistry GITAM Dental College and Hospital Gandhinagar Campus Rushikonda Visakhapatnam Visakhapatnam ANDHRA PRADESH 530045 India
Phone	9912860194
Fax
Email	mds.deepthi@gmail.com

Source of Monetary or Material Support

1st floor Room No 3 Department of Pediatric and Preventive Dentistry GITAM Dental College and Hospital Gandhinagar Campus Rushikonda Visakhapatnam 530045 Andhra Pradesh India

Primary Sponsor

Name	Dr Lakshmi Mounica Yerubandi
Address	1st floor Room No 3 Department of Pediatric and Preventive Dentistry GITAM Dental College and Hospital Gandhinagar Campus Rushikonda Visakhapatnam Andhra Pradesh 530045 India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Lakshmi Mounica Yerubandi	GITAM Dental College and Hospital	1st floor Room No 3 Department of Pediatric and Preventive Dentistry GITAM Dental College and Hospital Gandhinagar Campus Rushikonda Visakhapatnam Visakhapatnam ANDHRA PRADESH	9398137167 ylmounica99@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
ETHICAL COMMITTEE GITAM DENTAL COLLEGE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K040\|\|Pulpitis, (2) ICD-10 Condition: K041\|\|Necrosis of pulp, (3) ICD-10 Condition: K042\|\|Pulp degeneration,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional topical anesthetic gel application	Application of 20% Bupivacaine topical anesthetic gel at the site of injection, followed by inferior alveolar nerve block with 2% lignocaine with 1:80000 adrenaline with the total duration of the procedure being 5 minutes
Intervention	Modified V-Pen device	A modified intraoral vibrating device with a cooled tip applied near the injection site to provide vibratory and cooling stimulation for 2 minutes, followed by inferior alveolar nerve block with 2% lignocaine with 1:80000 adrenaline with the total duration of the procedure being 5 minutes
Intervention	Vibracool device	An extraoral vibratory cooling device placed near the injection site prior to administration of anesthesia to reduce pain for 2 minutes, followed by inferior alveolar nerve block with 2% lignocaine with 1:80000 adrenaline with the total duration of the procedure being 5 minutes.

Inclusion Criteria

Age From	5.00 Year(s)
Age To	10.00 Year(s)
Gender	Both
Details	1. No prior experience of dental anesthesia. 2. Indication of at least one dental procedure requiring Inferior Alveolar Nerve Block.

ExclusionCriteria

Details

1. Children who had a prior medical history of hospitalization or surgery, chronic illnesses, neuro behavioural disorders, local anaesthetic allergies, or infection at the site of injection were excluded.
2. History of fainting during injection
3. Children with special care needs.
4. Patients with painful dental experiences in the past and unco-operative children

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 and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Pain perception- Using Modified Wong Bakers faces pain rating scale	Post operative assessment with single scoring as baseline reading

Secondary Outcome

Outcome	TimePoints
Anxiety assessment- Using RMS-PS anxiety scale	two scorings will be taken that include 1.Baseline and 2.post operative assessment
Overall behaviour rating scale- Using HOUPT behavioural rating scale	Post operative assessment with single scoring as baseline reading

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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 3

Date of First Enrollment (India)

31/03/2026

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="0"
Months="6"
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
Modification(s)

The study is designed as a Randomized controlled trial (RCT) to evaluate the effectiveness of vibratory-cooling distraction techniques in reducing pain and improving behavior during Inferior alveolar nerve block (IANB) administration in children.

A total sample size of 90 children aged 5-10 years with no prior experience of local anesthesia will be included. Participants will be randomly allocated into 3 groups using a lottery method with 30 children in each group.

Group 1 : Extraoral Vibracool technique- where a vibratory cooling device will be placed extraorally on the mandibular ramus near the injection site prior and during IANB.

Group 2 : Intraoral cooled V-Pen technique- where a vibrating intraoral device with a cooled tip will be applied close to the injection site prior and during the procedure.

Group 3 - where IANB will be administered using the conventional technique.

All injections will be performed by a single operator using 2 % lignocaine with 1: 80000 adrenaline, following the standard IANB technique. Children will be allowed to rest in the dental chair for 5 minutes prior to the procedure and the entire procedure will be video recorded discreetly without the child’s awareness.

The outcomes assessed will include anxiety levels using the RMS Pictorial Scale, Pain perception using the Modified Wong- Baker faces pain rating scale , Child behavior using the HOUPT Behavior rating scale evaluated from video recordings by two blinded observers and and physiological parameters (pulse rate and oxygen saturation) to assess stress response.