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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05648981
• Other study ID #: Anesthesia_2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Other:
• Inferior Alveolar Nerve Block administration with laser irradiation
Patients will receive inferior alveolar nerve block local anesthesia followed by laser irradiation after completion of the operative procedure.
• Inferior Alveolar Nerve Block administration
Patients will not receive any laser irradiation after administration of inferior alveolar nerve block local anesthesia.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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