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

Not Applicable

Active, not recruiting

• Conditions: Anesthesia, Local
• Interventions: Other: Inferior Alveolar Nerve Block administration; Other: Inferior Alveolar Nerve Block administration with laser irradiation

• Registration Number: NCT05648981
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-01
• Study Start: 2022-11-02
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-11
• Last Update Submitted: 2022-12-11
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-13
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Inferior Alveolar Nerve Block administration	-
Test group	Inferior Alveolar Nerve Block administration with laser irradiation	-

Primary Outcome Measures

Name	Time	Method
Time to recovery of normal lip sensation	For two hours after the procedure	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

Secondary Outcome Measures

Name	Time	Method
Assessment of soft tissue injury	24 hours after the procedure	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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt