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The research did not start and the PI transitioned to another institution.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Additional injections of local anesthetic at the second visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayapriyaa Shanmugham, BDS MPH DrPH | BU Henry M. Goldman School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BU Henry M. Goldman School of Dental Medicine | Boston | Massachusetts | 02118 | United States |
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| Label | URL |
|---|---|
| Related publication. | View source |
| Related publication. | View source |
| Related publication. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000779 | Anesthetics, Local |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| articaine | Drug | A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered |
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| Restoration placement is at the end of the dental procedure, approximately 1 hour. |
The number of extra injections to achieve anesthesia will be documented for each participant. |
| At the completion of the second visit, approximately 1 hour. |
| View source |
| Related publication. | View source |
| Related publication. | View source |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |