Comparison of the" Intraosseous computer-controlled local anesthesia device" and" Inferior alveolar nerve block" in pulp therapy of primary molar teeth

Comparison of the efficacy and pain level" Intraosseous computer-controlled local anesthesia device" and" Inferior alveolar nerve block" in pulp therapy of primary molar teeth: randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240807062679N1

Enrollment

Registered

2024-08-20

Start date

2024-09-21

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Dental local anesthesia. local anesthesia

Interventions

Intervention 1: Intervention group1: In the first session, they receive the treatment of pulpotomy and stainless steel crown of the primary molar with the usual anesthesia method of lower alveolar ner

Eligibility

Sex/Gender

All

Age

4 Years to 6 Years

Inclusion criteria

Inclusion criteria: 4-6-year-old children's ability to understand and respond to a self-report visual pain assessment tool Children with a dental behavior score of 4 based on the Frankel Behavior Rating Scale Children who need pulpotomy treatment of primary molars in each half of the lower jaw Do not have a previous history of dental treatments that require local anesthesia injection Absence of sensitivity to local anesthetics At least 48 hours before the treatment, he has not taken any medications that may change the perception of pain (such as Analgesics). Absence of any systemic condition that prevents dental treatment under local anesthesia. (ASA1)

Exclusion criteria

Exclusion criteria: Children who show uncooperative behavior during treatment Lack of parental consent to participate in the study Having learning and communication problems

Design outcomes

Primary

Measure	Time frame
Heart rate. Timepoint: Measurement of heart rate before treatment, measurement of heart rate during injection, measurement of heart rate during treatment. Method of measurement: Measurement of heart rate with a pulse oximeter device.;Pain level. Timepoint: Pain level during injection, Pain level during treatment, Pain level at the end of treatment. Method of measurement: amount of pain during injection and at the end of treatment with Wong-Baker FACES visual pain scale, amount of pain during treatment using the FLACC scale (face, legs, activity, crying, consolability).;Effectiveness of injection. Timepoint: effectiveness of injection during treatment. Method of measurement: effectiveness of injection During treatment with the need to prescribe a supplemental injection.	—

Measure

Time frame

Heart rate. Timepoint: Measurement of heart rate before treatment, measurement of heart rate during injection, measurement of heart rate during treatment. Method of measurement: Measurement of heart rate with a pulse oximeter device.;Pain level. Timepoint: Pain level during injection, Pain level during treatment, Pain level at the end of treatment. Method of measurement: amount of pain during injection and at the end of treatment with Wong-Baker FACES visual pain scale, amount of pain during treatment using the FLACC scale (face, legs, activity, crying, consolability).;Effectiveness of injection. Timepoint: effectiveness of injection during treatment. Method of measurement: effectiveness of injection During treatment with the need to prescribe a supplemental injection.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansooreh Soltani

Shahid Beheshti University of Medical Sciences

soltanimansooreh5@sbmu.ac.ir+98 21 4414 4012

Outcome results

None listed

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