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Comparison of Articaine Mandibular Infiltration to Lidocaine Inferior Alveolar Nerve Block in Pediatric Patients

NCT04865848 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-05-09

No results posted yet for this study

Summary

This is a prospective, single-blind, parallel-design randomized controlled clinical trial that aims compare the effectiveness of articaine local infiltration to lidocaine inferior alveolar nerve block (IANB) for restorative treatment of primary mandibular molars (PMM). Four to 10-year-old children who needed PMM restorations are enrolled according to inclusion criteria and randomly allocated into the articaine or lidocaine group. One operator administers all local anesthesia (LA). Using the Modified Behavioral Pain Scale, 15 trained and calibrated examiners, blinded to LA type, evaluate the subjects' reactions during LA administration and treatment. Children rate their experience using the Wong-Baker FACES Pain Rating Scale. Subjects' blood pressure and pulse throughout the visit are recorded. Results are statistically analyzed using independent t-tests, Mann Whitney-U, and Repeated Measures ANOVA (P\<0.05).

Conditions

  • Anesthesia

Interventions

PROCEDURE

Dental local anesthesia

Dental local anesthesia

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Evelina Kratunova · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2022-05-05
Completion
2022-05-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865848 on ClinicalTrials.gov