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Comparison of the effectiveness of two local anesthesia methods

Comparison of the effectiveness of two local anesthesia methods: " Intraosseous computer-controlled local anesthesia device " and "conventional infiltration method" in pain control during pulpotomy of maxillary primary molars: randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251017067657N1
Enrollment
32
Registered
2025-11-17
Start date
2025-12-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Two methods of anesthesia for upper primary molars. Pulpitis

Interventions

Intervention 1: Intervention group 1: Intraosseous anesthesia: First, 20% benzocaine local anesthetic gel is used for superficial anesthesia. Then, intraosseous

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children aged 4-7 years with the ability to understand and respond to a self-report visual pain assessment tool. Children with a dental behavior score of 4 on the Frankl Behavior Rating Scale. Children who require pulpotomy treatment of primary molars in both upper quadrants. No sensitivity to local anesthetics. Have not taken any medications that may alter pain (such as painkillers) for at least 48 hours before treatment. Absence of any systemic conditions that would prevent dental treatment under local anesthesia (ASA1)

Exclusion criteria

Exclusion criteria: Teeth that show signs of infection or abscess. Teeth that have irreversible pulpitis.

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: During the intervention and immediately after the intervention is completed. Method of measurement: Wong-Baker FACES visual.;Child Cooperation. Timepoint: During intervention. Method of measurement: FLACC scale (face, legs, activity, crying, Consolability).;Heart rate. Timepoint: During intervention. Method of measurement: Pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirfarshad Esteghamat

Shahid Beheshti University of Medical Sciences

amifarrshad.esteghamat@sbmu.ac.ir+98 21 2990 2302

Outcome results

None listed

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