Clinical trial NCT03318952: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anesthesia, Dental
Pain, Postoperative
Keywords: lidocaine injection
articaine injections
pediatric dental anesthesia
post dental procedure pain
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain during anesthesia injection using the Wong-Baker faces scale
timeFrame: Anesthesia injection is usually about 10 min before the dental procedure starts.
measure: Pain during rubber dam placement using the Wong-Baker faces scale
timeFrame: Rubberdam placement is usually about 5 min before the dental procedure starts.
measure: Pain during tooth preparation using the Wong-Baker faces scale
timeFrame: Tooth preparation occurs during the dental procedure.
measure: Pain during pulp opening using the Wong-Baker faces scale
timeFrame: Pulp opening occurs during the dental procedure.
measure: Pain during restoration placement using the Wong-Baker faces scale
timeFrame: Restoration placement is at the end of the dental procedure, approximately 1 hour.
Secondary outcomes:
measure: Additional injections of local anesthetic at the first visit
timeFrame: At the completion of the first visit, approximately 1 hour.
measure: Additional injections of local anesthetic at the second visit
timeFrame: At the completion of the second visit, approximately 1 hour.
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU Henry M. Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: BU Henry M. Goldman School of Dental Medicine
name: Jayapriyaa Shanmugham, BDS MPH DrPH
role: PRINCIPAL_INVESTIGATOR
References: