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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Other: Inferior Alveolar Nerve Block administration with laser irradiation; Other: Inferior Alveolar Nerve Block administration

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Inferior Alveolar Nerve Block administration; Patients will not receive any laser irradiation after administration of inferior alveolar nerve block local anesthesia.
Experimental: Test group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Anesthesia_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No