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A clinical trial to evaluate the effectiveness of combined application of cold and vibration as compared to application of a numbing gel to reduce pain while giving injection for extracting lower teeth in 6-8 year old children.

Effectiveness of preanaesthetic application of combined mucosal vibration and cryotherapy v/s topical anesthetic gel on pain associated with inferior alveolar nerve block administration in children aged 6-8 years: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100981
Enrollment
40
Registered
2026-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: -

Interventions

Intervention1: Combined mucosal vibration and cryotherapy: Preanaesthetic application of combined mucosal vibration and cryotherapy using the newly developed small vibrating device fitted with an att

Sponsors

Dr Amina Shaji
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6-8 years requiring inferior alveolar nerve block. Children exhibiting a score of 3 and 4 on the Frankl s Behaviour Rating Scale. Children who have given assent and whose parents have given written informed consent for the procedure.

Exclusion criteria

Exclusion criteria: Children with prior experience of local anesthetic administration. Children with any known allergy to local anesthetic drug lignocaine. Medically compromised patients. Patients with physical, mental, developmental problems and learning disabilities. Patients with active pathology at the site of injection (draining abscess, swelling, ulcer) Patients with sensitivity to cold, sickle cell disease or Raynaud s disease.

Design outcomes

Primary

MeasureTime frame
Pain on injection as assessed by Wong-Baker faces pain rating scale and SEM scale Timepoint: Pain on injection will be assed by Wong-Baker faces pain rating scale at baseline, durin and after giving injection and by SEM Scale during and after giving injection.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Suchithra MS

Government Dental College Kottayam

suchithraharikesh@yahoo.co.in9847081035

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026