Comparative Evaluation of New Needleless Local Anesthetic System (INJEX) and Conventional Syringe Needle Technique during Pulpotomy Treatment: A Randomized Clinical Trial

Background: The dreaded sensation of pain in the dental chair has a significant impact on children's behavior. This study aimed to compare and contrast the perception of pain and patient behavior between the use of INJEX and the conventional syringe needle technique during pulpotomy among children.

Methods: A randomized clinical trial was designed and conducted among pediatric dentistry patients aged 6-12 years old. Fifty-eight children were divided into two groups, conventional syringe needle and INJEX, using simple randomization method applying the sequentially numbered, opaque, sealed envelope method of allocation concealment. Anesthesia was administered to the groups as local infiltration by a single operator following routine behavior guidance techniques. After 3 min, pulpotomy was performed using the standard protocol. The Face, Legs, Activity, Cry, Consolability (FLACC) scale and Wong-Baker FACES Pain Rating Scale (WBS) were used to assess the intensity of pain, while the Frankl behavior rating scale (FBRS) was used to assess the children's behavior.

Results: During anesthesia, most of the participants in the INJEX group (median = 3) had higher FBRS scores compared with the conventional syringe needle group (median = 2), and the difference was very highly significant (p-value < 0.001). Analyzing the FLACC scores during local anesthesia administration revealed a high statistical significance (p-value < 0.01) across the two groups. A very high statistically significant difference (p-values < 0.001) with higher WBS scores for pain intensity was seen in the group using conventional syringe needles.

Conclusions: INJEX administration significantly reduced the intensity of pain experienced by the children and helped maintain a positive attitude among them during pulpotomy. It provided a positive and comfortable experience for both the child and the practitioner. Therefore, it can serve as an excellent alternative to conventional needle anesthesia.