Pain, Postoperative Clinical Trial
Official title:
Efficacy of Articaine vs. Lidocaine When Used for Local Infiltration in Pediatric Dental Procedures
NCT number | NCT03318952 |
Other study ID # | H-33755 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2022 |
Est. completion date | June 2023 |
Verified date | October 2022 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 14 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | BU Henry M. Goldman School of Dental Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Additional injections of local anesthetic at the first visit | The number of extra injections to achieve anesthesia will be documented for each participant. | At the completion of the first visit, approximately 1 hour. | |
Secondary | Additional injections of local anesthetic at the second visit | The number of extra injections to achieve anesthesia will be documented for each participant. | At the completion of the second visit, approximately 1 hour. |
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