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

NCT ID: NCT05648981

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2022-12-30

Brief Summary

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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

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Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Test group

Group Type EXPERIMENTAL

Inferior Alveolar Nerve Block administration with laser irradiation

Intervention Type OTHER

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

Control group

Group Type ACTIVE_COMPARATOR

Inferior Alveolar Nerve Block administration

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Inferior Alveolar Nerve Block administration

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Anesthesia_2022

Identifier Type: -

Identifier Source: org_study_id