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Reversal of Anaesthesia with Diode Laser

NCT06841120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-24

No results posted yet for this study

Summary

Background: After local anesthesia, which is frequently used in pediatric dentistry, long-term soft tissue numbness can cause various problems. The aim of this study was to evaluate the effectiveness of PBMT in reversing soft tissue anaesthesia in children following local anaesthesia administration.

Methods: In a split-mouth randomized study, 40 children aged 4 to 9 years, eligible to receive local infiltration injection on both maxillary (n=20) and mandibular (n=20) right and left sides, will included. Maxillary and mandibular quadrants will be randomly assigned to laser or sham laser groups. Normality will assessed using the Kolmogorov-Smirnov test. Categorical variables between laser and control groups will compared using the McNemar paired sample test. Significance will be set at p\<0.05.

Conditions

  • Photobiomodulation Therapy

Interventions

DEVICE

Actual laser application

At approximately 45 minutes into the treatment session, subjects in the laser group received irradiation from a 4 W power, 810 nm diode laser (Fox; ARC Laser, GmbH, Nürnberg, Germany). The laser was operated in continuous mode, delivering 12-second shots per point using a therapy head with a point size of 0.38 cm². Each point received 6.3 J/cm² of laser energy, resulting in a total energy density of 37.8 J/cm² across 6 points.

DEVICE

Sham laser application

Sham laser was applied symbolically as a diffused closed laser (targeted beam) at the same distance and simultaneously. Evaluations after laser irradiation were conducted by a responsible specialist physician who was not involved in performing the treatment procedures.

Sponsors & Collaborators

  • Recep Tayyip Erdogan University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2024-01-18
Completion
2024-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06841120 on ClinicalTrials.gov