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

NCT04865848 | Terminated

• 1 other identifier: 2019-0160
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lidocaine; Articaine; Children; Dental; Local; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Effectiveness of articaine local infiltration to lidocaine inferior alveolar nerve block (IANB) for restorative treatment of primary mandibular molars (PMM).

  The primary outcome measure for this study is to compare the effectiveness of articaine local infiltration to lidocaine inferior alveolar nerve block (IANB) for restorative treatment of primary mandibular molars (PMM).

  up to 24 hour later (as the parent is able to contact the principal investigator and report any issues). Numerical value of 0 is assigned to the cases that did not report any adverse events and a numerical value of 1 to reported adverse outcomes.

Secondary Outcomes (1)

• Secondary outcome measures

  Immediately after procedure

Study Arms (2)

Mandibular infiltration dental anesthesia with Articaine

EXPERIMENTAL

Step-by-step: * Reflect tissue to expose injection site. * Orient bevel of the needle to be parallel to the bone and insert needle into mucobuccal fold * Proceed to the depth that approximates the apices of the buccal roots of the primary molars. * Aspirate. * Deposit bolus of local anesthetic slowly at a rate of 1 ml/min. * Remove needle. * A subsequent lingual infiltration is delivered. The armamentarium includes: 4% articaine HCl with 1:100,000 epinephrine (Septocaine ®, Septodont, Lancaster, Penn. USA) in 1.7 ml cartridges and 30-gauge short needle manufactured by Henry Schein® (Melville, N.Y., USA). All injections are given using a self-aspirating syringe (A-Titan, Orchard Park, N.Y., USA).

Procedure: Dental local anesthesia

Inferior Alveolar Nerve Block with Lidocaine

ACTIVE COMPARATOR

Step-by-step: * Dry injection site with gauze. * The barrel of the syringe should be directed on a plane between the two primary molars on the opposite side of the arch. It is advisable to inject a small amount of the solution as soon as the tissue is penetrated and to continue to inject minute quantities as the needle is directed toward the mandibular foramen. Insert to the depth that is adjacent to bone. * Aspirate. * Slowly inject bolus of anesthetic at a rate of 1 ml/min. * Remove needle. The armamentarium includes 2% lidocaine HCl with 1:100,000 epinephrine (Henry Schein ® Lidocaine, Novocol, Cambridge, Ontario, Canada) in 1.7 ml cartridges, as well as 27-gauge long needles manufactured by Henry Schein® (Melville, N.Y., USA). All injections are given using a self-aspirating syringe (A-Titan, Orchard Park, N.Y., USA).

Procedure: Dental local anesthesia

Interventions

Dental local anesthesia PROCEDURE

Dental local anesthesia

Inferior Alveolar Nerve Block with Lidocaine; Mandibular infiltration dental anesthesia with Articaine

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Per patient:
• Medical status: ASA I: a normal, healthy patient;
• Age range: from 4 to 10 year old patients (males and females);
• Past history of dental treatment using local anesthetic;
• Cooperative for dental treatment (Frankel 3 or 4);
• Obtained informed consent to participate in the study;
• English speakers;
• B. Per tooth:
• Primary mandibular molar; Tooth that requires restorative dental care, including intracoronal or extracoronal restorations, due to:
• Caries;
• Pulp treatment (indirect pulp therapy, pulpotomy, or pulpectomy);
• Developmental defects;
• Tooth surface loss (erosion/attrition);

You may not qualify if:

• A. Per patient:
• Medical status: patients in category II,III, IV, V, VI of the ASA physical status classification system:
• Age: younger than 4 years of age or older than 10 years of age;
• No history of dental treatment using local anesthetic;
• Uncooperative for dental treatment (Frankel 1 or 2);
• Informed consent to participate in the study not obtained;
• Non-English speakers;
• B. Per tooth:
• Tooth other than mandibular primary molar
• Tooth requiring extraction

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

College of Dentistry, Univesity of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Study Officials

• Evelina Kratunova

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: April 29, 2021
• Study Start: June 5, 2019
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)