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Articaine Efficacy and Safety for 3 Years Old Children

NCT05839548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-12-27

No results posted yet for this study

Summary

The primary purpose of this study is to determine the local anesthetic efficacy and safety of 4% Articaine compared 2% Mepivicaine in 3 years old children, by using infiltration technique for primary teeth that required restorative, pulp therapy, or dental extraction procedure, as assessed by measuring the pain experience during injection and treatment procedures, child's behavior during the procedure, and postoperative complications.

Conditions

  • Dental Caries in Children
  • Dental Diseases
  • Pulp Disease, Dental
  • Behavior, Child

Interventions

DRUG

Mepivacaine 2% with epinephrine 1:100,000

Local Anesthesia

DRUG

Articaine (4%) with epinephrine 1:100,000

Local Anesthesia

Sponsors & Collaborators

  • Qassim Health Cluster

    lead OTHER

Principal Investigators

  • Murad A. Alrashdi, ABPD · Qassim University

  • Asya A. Almansour, SBPD · Ministry of Health, Qassim cluster.

  • Atyaf A. Alhunti · Qassim University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
36 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Saudi Arabia

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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 NCT05839548 on ClinicalTrials.gov