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The purpose of the Research Study and Overview of Participation: This study will compare different approaches used to prevent pain when giving local anesthesia to numb the teeth while managing dental cavities and decay. Specifically, it seeks to determine which approach will reduce the pain and discomfort during or after the procedure. This will help dentists to choose the best approach to reduce patient's pain and discomfort and improve the overall experience of dental treatment.
Participants in the study would likely undergo the following:
This design ensures that the study collects reliable data on the effectiveness of the different topical anesthetic approaches while prioritizing patient safety and comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-medicated anelgesia | Experimental |
| |
| Placebo | Placebo Comparator | Placebo |
|
| Medicated anelgesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED | Device | Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score after local anesthesia administration, dental procedure, and 48 hours postoperatively. | Pain score based on Visual Analog Scale (1-10) with highest score indicates the most severe pain. | Within 5 minutes after local anesthesia administration, during dental procedure, directly after finishing the procedure, and 48 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score with prick pain test (PPT) | Pain score will be reported as "pain" or "no pain". | One minute after topical anesthesia. |
| Pain score with pulpal stimulation using electric pulp tester (EPT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Medicated analgesia | Other | Topical anesthesia (Benzocaine 20%) |
|
| Placebo | Other | Placebo with no intervention. |
|
Digital reading from 1 to 64 with the highest score indicates no pain response on electric stimulation.
| After 2 minutes of topical anesthesia. |
| Amount of local anesthesia to be given | Counting the number of used local anesthetic carpules. | At the end of dental procedure. |
| Need for additional analgesics | Count the number and dose of oral analgesics taken by the patient. | Within 48 hours postoperatively. |
| Reporting of any adverse effects, such as mucosal irritation, allergic reactions, and delayed pain relief. | Reported by the patient. | Within 48 hours postoperatively. |
| ID | Term |
|---|---|
| D011671 | Pulpitis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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