NCT03318952

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
4.9 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 5, 2017

Last Update Submit

October 29, 2022

Conditions

Anesthesia, DentalPain, Postoperative

Keywords

lidocaine injectionarticaine injectionspediatric dental anesthesiapost dental procedure pain

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Additional injections of local anesthetic at the first visit

    At the completion of the first visit, approximately 1 hour.

  • Additional injections of local anesthetic at the second visit

    At the completion of the second visit, approximately 1 hour.

Study Arms (2)

lidocaine then articaine

EXPERIMENTAL

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: lidocaineDrug: articaine

articaine then lidocaine

EXPERIMENTAL

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: lidocaineDrug: articaine

Interventions

lidocaineDRUG

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.

Also known as: local anesthetic
articaine then lidocainelidocaine then articaine
articaineDRUG

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

Also known as: local anesthetic
articaine then lidocainelidocaine then articaine

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BU Henry M. Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LidocaineAnesthetics, LocalCarticaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesThiophenesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jayapriyaa Shanmugham, BDS MPH DrPH

    BU Henry M. Goldman School of Dental Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 24, 2017

Study Start

September 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)