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Articaine vs Lidocaine for Pediatric Dental Procedures

NCT03318952 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-11-03

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia, Dental
  • Pain, Postoperative

Interventions

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.

DRUG

articaine

A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Jayapriyaa Shanmugham, BDS MPH DrPH · BU Henry M. Goldman School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

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 NCT03318952 on ClinicalTrials.gov