Reversal of Anaesthesia with Diode Laser

NCT ID: NCT06841120

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-18
• Study Completion Date: 2024-04-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Actual laser application

Group Type: EXPERIMENTAL

Actual laser application

Intervention Type: DEVICE

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.

Sham laser was applied symbolically

Group Type: SHAM_COMPARATOR

Sham laser application

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• - Children whose parents signed the written informed consent form and who themselves gave assent,
• Children with a Frankl behaviour rating scale score of 3 or 4,
• Children aged between 4 and 9 years old who can understand soft tissue sensation and respond to it,
• Children requiring treatment with local infiltration anaesthesia for multiple teeth in both the mandible and maxilla,
• Children with no history of allergy to materials used for anaesthesia or sulphite,
• Children who have not taken any analgesic medication at least 24 hours before treatment,
• Children without any systemic conditions that would interfere with dental treatment under local anaesthesia.

Exclusion Criteria

• Occurrence of an error during anaesthesia injection resulting in insufficient anaesthesia for treatment,
• Inability of the patient to provide clear assessments of response to soft tissue anaesthesia,
• Presence of systemic conditions that would prevent anaesthesia administration or dental treatment,
• Children requiring urgent dental treatment priority such as acute painful teeth.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Recep Tayyip Erdogan University

OTHER

Sponsor Role: lead

Responsible Party

Ayça Kurt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Recep Tayyip Erdoğan University, Faculty of Dentistry

Rize, Rize Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

RecepTayyipErdoganUniversity

Identifier Type: -

Identifier Source: org_study_id