The effect of DentalVibe on pain and discomfort during local anesthesia in children: a randomized clinical trial.

Objective: To evaluate the effectiveness of using DentalVibe during injection in comparison with the traditional injection technique, regarding pain and discomfort associated with buccal infiltration anesthesia (BIA) in pediatric patients. Method and materials: This randomized clinical trial included 6- to 12-year-old healthy children currently receiving nonurgent dental treatment on the maxillary arch that required BIA. In the control group, subjects received traditional BIA. In the test group, they received BIA with the aid of DentalVibe. A sample of 30 subjects per group was included. The mean ± SD age of the subjects was 9.18 ± 1.66 years. All the subjects were videotaped, and two trained and calibrated evaluators assessed the children's behaviors during the injection using the face, legs, activity, cry, consolability (FLACC) scale independently. Immediately after anesthesia administration, the subjects were administered the validated Arabic version of the Wong-Baker FACES scale ranging from 0 to 10. Results: Female subjects showed significantly higher mean FLACC and Wong-Baker FACES scale scores (2.20 ± 1.82 and 2.93 ± 3.05) compared with males (1.08 ± 1.37 and 1.12 ± 2.09) (P = .008 and P = .006, respectively). Multiple regression analysis showed that regardless of age and treatment group, females had significantly higher mean scores on the FLACC (β = 1.63, P = .002) and the Wong-Baker FACES scales (OR = 4.44, P = .004) than males. Conclusion: The use of DentalVibe did not significantly affect pain, discomfort, or time during BIA among pediatric patients compared with the traditional technique. Female children were more likely to report higher pain and discomfort scores during BIA administration regardless of age and anesthesia administration technique.