A device combining cold and vibration sounds like a simple way to make dental injections easier for children. But in this randomized trial, BUZZY did not significantly reduce pain or anxiety during the injection. Children’s fear of the injection of local anesthetic agents affects their cooperation in pediatric dentistry.

Different techniques are available to decrease the injection pain, including the use of precooling agents or vibrators. The study investigated the effectiveness of Buzzy, a device that transfers cold and external vibration to the injection site during the inferior alveolar nerve block injection.

Because available studies on BUZZY had quantitative and qualitative limitations, and because managing pain and stress matters in pediatric dentistry, a split-mouth study was designed to evaluate BUZZY during inferior alveolar nerve block. The trial was self-control, single-blind, and randomized, and it was carried out in a specialty dental clinic in Isfahan city from October twenty twenty to June twenty twenty-one.

The study followed the Declaration of Helsinki on medical protocol and ethics, and the regional Ethics Review Board of Isfahan University of Medical Sciences approved the study protocol. Informed consent was obtained from parents, and each child was questioned about their interest in taking part in the study.

Anxiety levels were assessed based on heart rate, and a pulse oximeter was connected to each child’s left index finger five minutes before the procedure. Heart rate was also recorded during the injection and five minutes after it.

The Wong–Baker and face, leg, activity, cry, consolability, or FLACC, scales were used to determine children’s pain severity during the injection. In the Wong–Baker scale, six different faces use a score from zero, indicating injection without pain, to ten, indicating the highest conceivable pain; immediately after injection, each child pointed to the face describing their pain and discomfort.

The FLACC scale scores the child’s face, feet, activities, crying, and adaptation from zero to two, then sums those scores from zero to ten; scores from four to six indicate moderate pain, while seven to ten indicate severe pain. Figure one traces participant flow through the clinical trial, from one hundred twenty children assessed for eligibility to forty-two randomized.

It records exclusions before and during follow-up, including children who declined, did not meet inclusion criteria, or did not return for the next session. After a two-week washout period, fifteen participants were allocated to each sequence and completed the study, yielding sixty IANB injections for analysis.

Table One presents means and standard deviations for Wong–Baker, FLACC, and Diff-PR, the pulse rate difference before and after the intervention, in the test and control sessions in Groups A and B. Intragroup analysis did not show significant differences between intervention and control sessions for Wong–Baker, FLACC, and Diff-PR, with p values of zero point nine, zero point one five, and zero point three eight.

For the period effect, FLACC and Diff-PR did not show significant differences, with p values of zero point ninety-seven and zero point fifty-one, while the Wong–Baker difference was significant at zero point zero four. Table one reports means and standard deviations for Wong–Baker, FLACC, and DIF PR across Buzzy and control sessions in Groups A and B.

The ANOVA columns separately report treatment, period, and carry-out effects; for example, the treatment p values are zero point nine for Wong–Baker, zero point one five for FLACC, and zero point three eight for DIF PR. This matters because it presents both the measured pain-related outcomes and the statistical structure used to compare sessions and periods.

Table Two compares the parameters in the whole study population, with thirty participants, without considering the priority of using BUZZY. There were no significant differences in any Wong–Baker, FLACC, or Diff-PR score, with p values of zero point eighty, zero point fifty-six, and zero point forty-six, respectively.

Table two compares the Buzzy and control groups across Wong–Baker, FLACC, and DIF PR scores using t-tests. The reported means plus or minus standard deviations are four point eight plus or minus four point two five versus four point five plus or minus three point nine nine for Wong–Baker; two point zero six plus or minus two point two one versus two point four plus or minus two point two five for FLACC; and eight point seven nine plus or minus fourteen point two five versus six point one seven plus or minus twelve point six nine for DIF PR.

The p-values—zero point eighty, zero point fifty-six, and zero point forty-six—show no statistically significant differences in these measures. The study had some limitations, and its results concern only cooperative children receiving inferior alveolar nerve block injections; they cannot be extended to noncooperative children, other injections, or children younger than six years.

The operator recording heart rates and questioning the children about their pain were not blinded. Future studies could evaluate BUZZY in the three-and-a-half to six-year age group and ask children to score the Wong–Baker scale before injection as well.

Other scales, including SEM, a behavioral scale, and children’s fear scale, a self-report scale for evaluating pain, can also be used. The BUZZY tool did not significantly decrease dental pain in six- to twelve-year-old children during the inferior alveolar nerve block injection.

For cooperative children aged six to twelve receiving an inferior alveolar nerve block, BUZZY did not significantly decrease dental pain, and the study’s anxiety measure also showed no significant benefit.