NCT06314984

Jet Injectors Versus Conventional Anesthetic Technique in Children

Effectiveness of Jet Injector Local Anesthesia Versus Conventional Technique in Primary Molars Pulpotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

Summary

This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of 1. Pain level during the administration of local anesthesia in children. 2. Their effectiveness during pulpotomy procedures in primary molars. Whether comfort-in jet injector device will achieve sufficient anesthesia for the procedures undertaken during pulpotomy or not when compared to the conventional technique and the pain levels of both techniques during the anesthesia step.

Detailed description

Cooperative healthy seventy-six children required pulpotomy treatment in primary molars aged 4 to 7 years with no previous dental local anesthetic experience, were recruited from the pediatric dental clinic, Faculty of Dentistry, Mansoura university. The patients' behavior was categorized as positive or definitely positive according to Frankl Behavior Scale. All children were divided randomly into two main groups (38 each), control group I (conventional needle) and experimental group II (Comfort-in). Then two sub-group were constructed, each consists of 19 children. Sub-group I A and II A (IANB) and sub-group I B and II B (maxillary infiltration), the chief complaint of the child was the main determinant for the side (right or left) to be injected. The jet injector technique was applied in 2 shots with (0.5 ml) each, to unify the dose with the conventional technique. After testing the anesthesia's profoundness, pulpotomy steps proceeded. Pain evaluation was set up according to two different subjective and objective scales, the WBFP and FLACC scales. All parents of the children included in this study answered a post-treatment questionnaire to measure the degree of satisfaction regarding the technique that was selected for his/her child. Data were collected, tabulated, and statistically analyzed.

Conditions

• Anesthesia

Interventions

Type	Name	Description
OTHER	Group I A (Conventional needle syringe)	The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the conventional needle syringe \[Inferior Alveolar Nerve Block\].
OTHER	Group I B (Conventional needle syringe)	The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the conventional needle syringe \[Infiltration\].
DEVICE	Group II A (Comfort-in Jet Injector)	The injection site was isolated using a cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the needleless Comfort-in jet injector \[Inferior Alveolar Nerve Block\].
DEVICE	Group II B (Comfort-in Jet Injector)	The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the needleless Comfort-in jet injector \[Infiltration\].

Timeline

• Start date: 2021-07-21
• Primary completion: 2022-11-15
• Completion: 2023-03-21
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: Egypt