Jet Injectors Versus Conventional Anesthetic Technique in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2023-03-21

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group I A (Conventional neddle syringe)

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

Group Type ACTIVE_COMPARATOR

Group I A (Conventional needle syringe)

Intervention Type OTHER

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 \[Inferior Alveolar Nerve Block\].

Group I B (Conventional needle syringe)

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

Group Type ACTIVE_COMPARATOR

Group I B (Conventional needle syringe)

Intervention Type OTHER

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 \[Infiltration\].

Group II A (Comfort-in Jet Injector)

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

Group Type EXPERIMENTAL

Group II A (Comfort-in Jet Injector)

Intervention Type DEVICE

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 \[Inferior Alveolar Nerve Block\].

Group II B (Comfort-in Jet Injector)

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

Group Type EXPERIMENTAL

Group II B (Comfort-in Jet Injector)

Intervention Type DEVICE

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 \[Infiltration\].

Interventions

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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 \[Inferior Alveolar Nerve Block\].

Intervention Type 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 \[Infiltration\].

Intervention Type OTHER

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 \[Inferior Alveolar Nerve Block\].

Intervention Type 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 \[Infiltration\].

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes