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

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05648981

Collaborator

(none)

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

16.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Other: Inferior Alveolar Nerve Block administration with laser irradiation Other: Inferior Alveolar Nerve Block administration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT05648981

Other Study ID Numbers:

Anesthesia_2022

First Posted:

Dec 13, 2022

Last Update Posted:

Dec 13, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 13, 2022