Articaine vs Lidocaine for Pediatric Dental Procedures

Efficacy of Articaine vs. Lidocaine When Used for Local Infiltration in Pediatric Dental Procedures

The purpose of this study is to compare the efficacy of two types of local anesthesia (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on lower teeth in pediatric patients. The patients will require similar dental operative procedures on both right and left sides of the mandible in order to qualify for this study. The study will require at least two dental appointments, where a randomized, cross-over study methodology will be utilized. All subjects will be treated by the same dentist. The comfort of the patient will be assessed at various points during the procedure using the Wong-Baker Faces Scale.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative; Anesthesia, Dental
• Intervention / Treatment: Drug: lidocaine; Drug: articaine

Detailed Description

This study will compare articaine to lidocaine with overall quality of anesthesia. When administering lidocaine, the investigator will follow standard of care by administering a buccal infiltration injection followed by 2-3 interpapillary injections, one at each gingival papilla where the rubber dam clamp will be placed and possibly more if needed in areas where dental treatment will be provided. A single buccal infiltration injection of articaine will be administered, with the hypothesis that articaine is a stronger anesthestic and will deliver palatal anesthesia with a single injection, eliminating the interpapillary injections required for lidocaine to achieve adequate soft tissue anesthesia. The comfort of the patient during multiple steps of the dental treatment will be recorded. A randomized, cross-over methodology will be used. This study seeks to find whether adequate anesthesia in the mandible can be achieved with a single injection of articaine in the buccal aspect of the jaw instead of having to administer multiple injections of lidocaine, which can increase patient anxiety and discomfort. By decreasing the number of injections needed for children during dental treatment while providing adequate local anesthesia, dentists can provide more comfortable care to their pediatric patients.

Specific Aims/ Hypothesis

-Specific Aim 1: To compare articaine to lidocaine with achieving effective local anesthesia in the mandible and upper arch of pediatric dental patients.

Hypothesis: The solubility of articaine will provide more effective anesthetic delivery through the soft and hard tissue of the mandible following buccal infiltration, eliminating the need for multiple injections.

-Specific Aim 2: To identify which type of anesthetic provides the best patient experience by way of measuring patient comfort at various stages of the dental procedure.

Hypothesis: The patient will have an equally comfortable experience during the dental procedure when articaine or lidocaine is used.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • BU Henry M. Goldman School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients receiving dental care at Boston Medical Center Pediatric Dental Clinic, Boston University Pediatric Oral Health Center, and East Boston Neighborhood Health Center Pediatric Dental Clinic
• Patients needing similar restorative dental procedures to primary molar teeth on both sides of the maxillary arch or upper arch
• Boys and girls between ages 4 to 14 years
• English speaking and be able to understand verbal assent.

Exclusion Criteria:

• Patients for whom the use of articaine is contraindicated such as patients with Acetylcholine esterase deficiency
• Patients for whom the use of lidocaine is contraindicated in patients taking metronidazole

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lidocaine then articaine; For the first dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed. For the second dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.	Drug: lidocaine; A buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed of 2% lidocaine with 1:100,000 epinephrine will be administered.; Other Names: local anesthetic; Drug: articaine; A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered; Other Names: local anesthetic
Experimental: articaine then lidocaine; For the first dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. For the second dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed.	Drug: lidocaine; A buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed of 2% lidocaine with 1:100,000 epinephrine will be administered.; Other Names: local anesthetic; Drug: articaine; A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered; Other Names: local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during anesthesia injection using the Wong-Baker faces scale	Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.	Anesthesia injection is usually about 10 min before the dental procedure starts.
Pain during rubber dam placement using the Wong-Baker faces scale	Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.	Rubberdam placement is usually about 5 min before the dental procedure starts.
Pain during tooth preparation using the Wong-Baker faces scale	Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.	Tooth preparation occurs during the dental procedure.
Pain during pulp opening using the Wong-Baker faces scale	Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.	Pulp opening occurs during the dental procedure.
Pain during restoration placement using the Wong-Baker faces scale	Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.	Restoration placement is at the end of the dental procedure, approximately 1 hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional injections of local anesthetic at the first visit	The number of extra injections to achieve anesthesia will be documented for each participant.	At the completion of the first visit, approximately 1 hour.
Additional injections of local anesthetic at the second visit	The number of extra injections to achieve anesthesia will be documented for each participant.	At the completion of the second visit, approximately 1 hour.

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Jayapriyaa Shanmugham, BDS MPH DrPH, BU Henry M. Goldman School of Dental Medicine

Publications and helpful links

Helpful Links

• Related publication.
• Related publication.
• Related publication.
• Related publication.
• Related publication.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 21, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: lidocaine injection; articaine injections; pediatric dental anesthesia; post dental procedure pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local; Carticaine
• Other Study ID Numbers: H-33755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes