Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children

Study Overview
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Brief Summary
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Inevitable problems were reported following the injection of local anesthesia in pediatric dental procedures, which can last until the elimination of soft tissue anesthesia. Purpose of the study: To evaluate the effectiveness of diode laser photobiomodulation therapy on the reversal of soft tissue anesthesia (STA) in children following inferior alveolar nerve block anesthesia.

Official Title
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Effectiveness of Photobiomodulation Using Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children: a Randomized Controlled Clinical Trial

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Other: Inferior Alveolar Nerve Block administration with laser irradiation
* Other: Inferior Alveolar Nerve Block administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of operative dental procedures, requiring inferior alveolar nerve (IANB) anesthesia. Healthy patients (physical status ASA I). Definitely positive or positive patients on the Frankl behavior scale. No reported allergies to LA, epinephrine or sulfites. Normal lip sensation before administration of LA Exclusion Criteria: Patients requiring surgical procedures (i.e. extractions). Patients who will show excessive fear to the Transcutaneous Electric Nerve Stimulator (TENS) device and provide a false-positive response on inactivated electrode (absence of current) using the Venham scale. Patients who will not be trainable in the standardized lip tapping procedure (could not learn to distinguish the anesthetized numb side from the non-anesthetized side). Patients who will not achieve profound numbness after initial LA administration, requiring additional anesthesia using SEM scale.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Other: Inferior Alveolar Nerve Block administration with laser irradiation<br>* Patients will receive inferior alveolar nerve block local anesthesia followed by laser irradiation after completion of the operative procedure.<br>|
| Active Comparator: Control group<br> | Other: Inferior Alveolar Nerve Block administration<br>* Patients will not receive any laser irradiation after administration of inferior alveolar nerve block local anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery of normal lip sensation | Patients will be asked to rate the lower lip numbness on the anesthetized side in comparison to the contralateral non-anesthetized side as described previously. Patients responses will be recorded every time as yes or no. the number of minutes elapsed from exposure to laser irradiation to the first reported a normal sensation of the lower lip | For two hours after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of soft tissue injury | A telephone call will be done inquiring on any trauma, injury, swelling or biting marks on the lower lip after 24 h. this will be recorded as Yes/no responses | 24 hours after the procedure |