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Articaine vs Lidocaine for Pediatric Dental Procedures

Primary Purpose

Anesthesia, Dental, Pain, Postoperative

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lidocaine
articaine
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Dental focused on measuring lidocaine injection, articaine injections, pediatric dental anesthesia, post dental procedure pain

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BU Henry M. Goldman School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lidocaine then articaine

articaine then lidocaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Additional injections of local anesthetic at the first visit
The number of extra injections to achieve anesthesia will be documented for each participant.
Additional injections of local anesthetic at the second visit
The number of extra injections to achieve anesthesia will be documented for each participant.

Full Information

First Posted
October 5, 2017
Last Updated
October 29, 2022
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT03318952
Brief Title
Articaine vs Lidocaine for Pediatric Dental Procedures
Official Title
Efficacy of Articaine vs. Lidocaine When Used for Local Infiltration in Pediatric Dental Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The research did not start and the PI transitioned to another institution.
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Dental, Pain, Postoperative
Keywords
lidocaine injection, articaine injections, pediatric dental anesthesia, post dental procedure pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lidocaine then articaine
Arm Type
Experimental
Arm Description
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.
Arm Title
articaine then lidocaine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lidocaine
Other Intervention Name(s)
local anesthetic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
articaine
Other Intervention Name(s)
local anesthetic
Intervention Description
A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered
Primary Outcome Measure Information:
Title
Pain during anesthesia injection using the Wong-Baker faces scale
Description
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.
Time Frame
Anesthesia injection is usually about 10 min before the dental procedure starts.
Title
Pain during rubber dam placement using the Wong-Baker faces scale
Description
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.
Time Frame
Rubberdam placement is usually about 5 min before the dental procedure starts.
Title
Pain during tooth preparation using the Wong-Baker faces scale
Description
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.
Time Frame
Tooth preparation occurs during the dental procedure.
Title
Pain during pulp opening using the Wong-Baker faces scale
Description
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.
Time Frame
Pulp opening occurs during the dental procedure.
Title
Pain during restoration placement using the Wong-Baker faces scale
Description
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.
Time Frame
Restoration placement is at the end of the dental procedure, approximately 1 hour.
Secondary Outcome Measure Information:
Title
Additional injections of local anesthetic at the first visit
Description
The number of extra injections to achieve anesthesia will be documented for each participant.
Time Frame
At the completion of the first visit, approximately 1 hour.
Title
Additional injections of local anesthetic at the second visit
Description
The number of extra injections to achieve anesthesia will be documented for each participant.
Time Frame
At the completion of the second visit, approximately 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayapriyaa Shanmugham, BDS MPH DrPH
Organizational Affiliation
BU Henry M. Goldman School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
BU Henry M. Goldman School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/9188235
Description
Related publication.
URL
http://glidewelldental.com/education/chairside-dental-magazine/volume-5-issue-4/patients-who-make-a-dentist-most-anxious-about-giving-injections/
Description
Related publication.
URL
https://www.ncbi.nlm.nih.gov/pubmed/10832257
Description
Related publication.
URL
https://www.ncbi.nlm.nih.gov/pubmed/11217590
Description
Related publication.
URL
https://www.ncbi.nlm.nih.gov/pubmed/16759322
Description
Related publication.

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Articaine vs Lidocaine for Pediatric Dental Procedures

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