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

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 - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106372
Enrollment
90
Registered
2026-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis Health Condition 2: K041- Necrosis of pulp Health Condition 3: K042- Pulp degeneration

Interventions

Intervention1: 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

Sponsors

Dr Lakshmi Mounica Yerubandi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. No prior experience of dental anesthesia. 2. Indication of at least one dental procedure requiring Inferior Alveolar Nerve Block.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Secondary

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

Primary

MeasureTime frame
Pain perception- Using Modified Wong Bakers faces pain rating scaleTimepoint: Post operative assessment with single scoring as baseline reading

Countries

India

Contacts

Public ContactDr Jayalakshmi Pandranki

GITAM Dental College and Hospital

mds.deepthi@gmail.com9912860194

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026