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comparison of needle free iontophoresis and injection anesthesia in children during dental procedures

Comparative evaluation of iontophoresis infused anesthetic gel and conventional local anaesthesia in pediatric dental procedures among 6-12 years old children: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099944
Enrollment
108
Registered
2025-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

None listed

Interventions

Intervention1: Iontophoresis infused topical anesthetic gel: Needle free anesthesia, iontophoresis device using low-voltage electrical current to enhance trans-mucosal drug delivery of anesthetic gel.

Sponsors

Dr. Shailaben Chaudhary
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects who: undergo treatment for the first time. require bilateral extraction/restoration of primary teeth who need LA exhibit cooperative behaviour (Frankl scale 3 or 4). demonstrate competency in using the Wong-Baker FACES pain rating scale.

Exclusion criteria

Exclusion criteria: Subjects: known drug allergies towards the anesthetic agents. Presence of dental abscess,local infection which lowers the effect of anesthesia. Pre-existing debilitating systemic dis eases. Parents do not consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Pain experienced during the dental procedure, measured using the Wong Baker FACES Pain Rating Scale (0 10) to assess the effectiveness of needle-free iontophoresis compared with conventional local infiltration by reducing procedural painTimepoint: Pain score will be assessed during the dental procedure and immediately after completion of the procedure.

Secondary

MeasureTime frame
Onset time of anesthesia (minutes), duration of anesthesia (minutes), change in heart rate & blood pressure, child behaviour (Frankl scale), need for supplemental anesthesia (Yes/No), & parent/child satisfaction (5-point Likert scale)Timepoint: Onset time recorded from application to onset of anesthesia; duration recorded until return of sensation; physiological parameters recorded before, during & after procedure; child behavior assessed during procedure; need for supplemental anesthesia during the procedure; parent-child satisfaction assessed immediately after the visit

Countries

India

Contacts

Public ContactDr Shailaben Chaudhary

Narsinhbhai Patel Dental College and Hospital

shaila25chaudhary@gmail.com8238784535

Outcome results

None listed

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