Clinical trial NCT06314984: Jet Injectors Versus Conventional Anesthetic Technique in Children
Official title: Effectiveness of Jet Injector Local Anesthesia Versus Conventional Technique in Primary Molars Pulpotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Jet injector
Needle
Comfort-in
Pain perception
Needleless
Pediatric Dentistry
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Children who require local anesthetic injection for pulpotomy.
2. Cooperative children (positive or definitely positive on Frankel's scale).
3. Children who had no previous dental local anesthetic experience, to avoid the influence of a negative or positive memory.
4. Children who have been determined to be healthy and free of systemic diseases.
5. Children who do not have any contraindications for administering a local anesthetic agent.

Exclusion Criteria:

1. Children suffering from medical illness, neurosensory disturbances, and psychiatric disorders.
2. Children who could not comprehend the pain measures.
3. Children with emergencies and acute dental conditions.

Primary outcomes:
measure: Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale
timeFrame: During adminstration of local anesthesia procedures.
measure: Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale
timeFrame: During the pulpotomy procedure.
measure: Pain level during administration of local anesthesia in children by FLACC scale.
timeFrame: During adminstration of local anesthesia procedures.
measure: Pain levels during pulpotomy procedures steps by FLACC scale.
timeFrame: During the pulpotomy procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University.
state: Dakahlia
Study officials:
References: