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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05648981
Enrollment
32
Registered
2022-12-13
Start date
2022-11-02
Completion date
2022-12-30
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

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.

Interventions

OTHERInferior 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.

OTHERInferior Alveolar Nerve Block administration

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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to recovery of normal lip sensationFor two hours after the procedurePatients 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

MeasureTime frameDescription
Assessment of soft tissue injury24 hours after the procedureA 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026