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Comparison of two Cryotherapy based Topical Anesthetic Techniques to reduce Pain and Anxiety amongst Children during Local Anesthetic Injection

Comparative Effectiveness of two Cryotherapy Topical Anesthetic techniques on Pain perception in Children with AI assisted Anxiety assessment: A Spilt-mouth Randomized Controlled Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108202
Enrollment
20
Registered
2026-04-13
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: K040- Pulpitis

Interventions

Intervention1: Xylitol-Lignocaine infused ice popsicle: Xylitol-lignocaine infused ice popsicle applied locally at the site of injection for 2 minutes prior to administration of local anesthesia Contr

Sponsors

Dr Kajal Jaiswal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Positive (+) and definitely positive (++) children according to Frankl behavior rating scale 2. Children who required bilateral nerve block for tooth extraction or endodontic procedure 3. Children who cleared lignocaine patch test before initiation of the study.

Exclusion criteria

Exclusion criteria: 1. Children with special health-care needs. 2. Children allergic to LA. 3. Patients with peripheral vascular disease, Raynaud s disease, urticaria, and hypersensitivity to cold. 4. Children with dental emergencies such as trauma.

Design outcomes

Primary

MeasureTime frame
Pain perception during local anesthetic administration assessed using Wong Baker Faces Pain Rating Scale and FLACC scale at the time of injection.Timepoint: During injection (needle insertion and local anesthetic deposition)

Secondary

MeasureTime frame
Pulse rate and oxygen saturation measured using pulse oximeter.Timepoint: Pre-treatment, During Treatment and Post-treatment.

Countries

India

Contacts

Public ContactDr Lumbini Pathivada

Rungta College of Dental Sciences and Research

drlumbinip@gmail.com7830008856

Outcome results

None listed

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