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Completed

NCT Number: NCT04061265

Articaine Efficacy and Safety for Children Below Age of 4-years

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

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Key information

Conditions

Behaviour Assessment Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

37 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ngwa Khattab

Minya, Minya Governorate, 61111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion criteria

  • The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Treatment and study plan

Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

Drug

Local anesthetic agent

lidocaine hydrochloride 2% and epinephrine 1:100000

Drug

Local anesthetic agent

Primary outcomes

  1. Pain assessment

    Time frame: During the procedures

    FLACC scale

  2. Behavior

    Time frame: before and after the procedures

    Frankl behaviour scale

Secondary outcomes

  1. postoperative complications

    Time frame: 24 hours after the procedures

    Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2019
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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