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Assessment of a novel device for alleviating pain and anxiety during local anesthesia administration in children.

Assessment of an innovative device in alleviating pain and anxiety during local anesthesia administration in children: A split-mouth crossover study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107572
Enrollment
32
Registered
2026-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: K02- Dental caries

Interventions

Intervention1: cold and vibrational device: The cold and vibrational device will be place on the zygomatic arch during conventional local anesthesia administration technique. Control Intervention1: co

Sponsors

SRM kattankulathur Dental college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)4 12-year-old children requiring local anesthesia administration for bilateral pulp therapy in maxillary posterior teeth. 2)Rated as definitely positive or positive on the Frankl behaviour rating scale 3) Children with no previous experience of intraoral local anesthesia .

Exclusion criteria

Exclusion criteria: 1) Children with systemic illness or known allergy to local anesthesia or any of its components. 2) Children belonging to definitely negative or negative on the Frankl behaviour rating scale. 3) Children whose parents did not give consent for participation in the study.

Design outcomes

Primary

MeasureTime frame
The innovative cold and vibrating device will significantly reduce pain, anxiety, and discomfort during local anesthesia administration in children.Timepoint: Time point 1-1 month (Development of cold and vibrating device) Time point 2-2 (Development of cold and vibrating device) Time point 3-3 month (Development of cold and vibrating device) Time point 4-4 month (Development of cold and vibrating device) Time point 5-5 month (Development of cold and vibrating device) Time point 6-6 month (Development of cold and vibrating device) Time point 7-7 month (Development of cold and vibrating device) Time point 8-8 month (Development of cold and vibrating device) Time point 9-9 month (Development of cold and vibrating device) Time point 10-10 month (Assessment of the device in alliviating pain and anxiety during local anesthesia administration) Time point 11-11 month (Assessment of the device in alliviating pain and anxiety during local anesthesia administration) Time point 12-12 month (Assessment of the device in alliviating pain and anxiety during local anesthesia administration)—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactShivangi Dixit

SRM kattankulathular Dental college

scd61299@gmail.com9943361299

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026