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Reducing Pain in Children During Dental Injections: A Study Using Vibration and Cooling Together

Effectiveness of Combined Extraoral Vibration and Cooling on Pain Perception during IANB administration in Children: a split mouth randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090744
Enrollment
40
Registered
2025-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K038- Other specified diseases of hard tissues of teeth

Interventions

Intervention1: extraoral vibration and cooling device: The extraoral vibration and cooling device was activated 30 seconds before administration of the local anesthetic and remained operational throug

Sponsors

Harsh Baldawa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged four to nine years Requiring bilateral LA for dental procedures such as pulp therapy, extraction, or restorative treatment Medically healthy children with no systemic conditions affecting pain perception Cooperative behavior rated as three or four on the Frankl Behavior Rating Scale

Exclusion criteria

Exclusion criteria: Neurological or cognitive impairments History of adverse reactions to local anesthetics Presence of intraoral soft tissue lesions or infections at the injection site Use of analgesics or sedatives within 24 hours prior to the procedure

Design outcomes

Primary

MeasureTime frame
pain perception that is subjective and objective painTimepoint: baseline - while local anesthesia administration

Secondary

MeasureTime frame
AnxietyTimepoint: baseline - during administration of local anesthesia

Countries

India

Contacts

Public ContactHarsh Sanjaykumar Baldawa

Saveetha Dental College and Hospital

dr.priyatham@gmail.com9490549454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026