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

NCT05648981 | Unknown

• 1 other identifier: Anesthesia_2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of soft tissue injury

  24 hours after the procedure

Study Arms (2)

Test group

EXPERIMENTAL

Other: Inferior Alveolar Nerve Block administration with laser irradiation

Control group

ACTIVE COMPARATOR

Other: Inferior Alveolar Nerve Block administration

Interventions

Inferior Alveolar Nerve Block administration with laser irradiation OTHER

Patients will receive inferior alveolar nerve block local anesthesia followed by laser irradiation after completion of the operative procedure.

Test group

Inferior Alveolar Nerve Block administration OTHER

Patients will not receive any laser irradiation after administration of inferior alveolar nerve block local anesthesia.

Control group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 13, 2022
• Study Start: November 2, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

EG (1)