Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actual laser application | Experimental |
| |
| Sham laser was applied symbolically | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actual laser application | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia reversal time | Until the first reversal of anesthesia, a palpation technique will be used to record every 10 minutes. With this technique, the presence of a sense of touch and tingling will be questioned. In order to obtain an objective answer, the child will be asked whether he/she knows what a tingling sensation is based on his/her previous experiences and will be told what and how this sensation is. | up to 30 minutes after procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdoğan University, Faculty of Dentistry | Rize | Rize Province | 53100 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham laser application | 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. |
|