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Effectiveness of an external cooling and vibrating device versus vibrating by hand in reducing discomfort of dental injection in child patients

Effectiveness of an external cooling and vibrating device versus counterstimulation in reducing discomfort of inferior alveolar nerve block in paediatric dental patients: A single blinded randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033124
Enrollment
123
Registered
2021-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

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

Interventions

Intervention1: External cooling and vibrating device: Placed extraorally over the cheeks during the administration of inferior alveolar nerve block Intervention2: Counterstimulation: Manually vibratin

Sponsors

Dr Vandana P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 5-7 years who require dental procedures in posterior teeth that warranted the use of only inferior alveolar nerve block. 2.Children who had no prior experience of dental anesthesia 3.Children rated as positive (+) or negative (-) on the Frankl behaviour rating scale. 4.Children with proper parental consent. 5.Children with no systemic illness, allergies,medications etc.

Exclusion criteria

Exclusion criteria: 1.Children with congenital syndromes and history of diagnosed neuro-behavioural disorders. 2.Children with any problem associated with the site of application of the cooling and vibrating device. 3.Children who exhibit Franklâ??s definitely negative behaviour during the course of procedure

Design outcomes

Primary

MeasureTime frame
Pain and Anxiety measurement using Wong Baker Faces Pain Rating Scale, Face Leg Activity Cry Consolability Scale, pulse oximeter readingsTimepoint: 5 minutes Before and After the administration of inferior alveolar nerve block—

Secondary

MeasureTime frame
Compare the mean pulse oximeter, Wong Baker Faces Pain Rating Scale and Face Leg Activity Cry Consolability scale readings between the study groupsTimepoint: 5 minutes Before and after the administration of inferior alveolar nerve block—

Countries

India

Contacts

Public ContactDr Madhu S

Government Dental College Kozhikode

madhupedo@gmail.com9447775435

Outcome results

None listed

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