NCT06841120

Reversal of Anaesthesia with Diode Laser

Evaluation of Photobiomodulation Therapy with Diode Laser in Reversal of Maxillary and Mandibular Soft Tissue Local Anaesthesia in Paediatric Dentistry: Randomized Clinical Trial:a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Recep Tayyip Erdogan University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-01-18
• Completion: 2024-04-30
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: Turkey (Türkiye)