Jet Injectors Versus Conventional Anesthetic Technique in Children

Mansoura University

Status: Completed

Conditions: Anesthesia

Treatments: Other: Group I B (Conventional needle syringe); Other: Group I A (Conventional needle syringe); Device: Group II A (Comfort-in Jet Injector); Device: Group II B (Comfort-in Jet Injector)

Study type: Interventional

Funder types: Other

Identifiers

NCT06314984

A10040521

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Group I A (Conventional neddle syringe)

Active Comparator group

Description:

The injection was done in the mandible by the conventional needle syringe \[Inferior Alveolar Nerve Block\].

Treatment:

Other: Group I A (Conventional needle syringe)

Group I B (Conventional needle syringe)

Active Comparator group

Description:

The injection was done in the maxilla by the conventional needle syringe \[Infiltration\].

Treatment:

Other: Group I B (Conventional needle syringe)

Group II A (Comfort-in Jet Injector)

Experimental group

Description:

The injection was done in the mandible by the needleless Comfort-in jet injector \[Inferior Alveolar Nerve Block\].

Treatment:

Device: Group II A (Comfort-in Jet Injector)

Group II B (Comfort-in Jet Injector)

Experimental group

Description:

The injection was done in the maxilla by the needleless Comfort-in jet injector \[Infiltration\].

Treatment:

Device: Group II B (Comfort-in Jet Injector)