Articaine vs Lidocaine for Pediatric Dental Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, Dental Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

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.

articaine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

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.

articaine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

articaine

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

Intervention Type DRUG

Other Intervention Names

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local anesthetic local anesthetic

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No