Pain Perception Comparison of Computerized vs Conventional Injection Methods

Study Overview
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Brief Summary
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This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.

Detailed Description
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The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.

Official Title
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A Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems

Conditions
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Pain Perception, Local Anesthesia

Intervention / Treatment
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* Device: Conventional Syringe
* Device: STA Single Tooth Anesthesia® System.
* Device: Star Pen anesthesia device.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy children (5-8) years old, and free from systemic diseases. Children who require local anesthetic injection for any dental treatment. Cooperative children (positive or definitely positive on Frankel's scale). Children who have no contraindications to the usage of selected local anesthetic agents. Exclusion Criteria: All that does not correspond to inclusion criteria.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Selected children will be divided randomly into 3 groups: Control group (Group I). STA group (Group II). Star pen group (Group III).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I: Control Group<br>Use a conventional syringe to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a conventional syringe to inject anesthetic solution by buccal infiltration (BI) technique. | Device: STA Single Tooth Anesthesia® System.<br>* Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration.<br>Device: Star Pen anesthesia device.<br>* Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration.<br>|
| Experimental: Group II: STA group<br>Use STA Wand® (CCLA) to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use STA Wand® (CCLA) to inject anesthetic solution by buccal infiltration (BI) technique. | Device: Conventional Syringe<br>* Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.<br>Device: Star Pen anesthesia device.<br>* Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration.<br>|
| Experimental: Group III: Star pen group<br>Use a Star Pen device to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a Star Pen device to inject anesthetic solution by buccal infiltration (BI) technique. | Device: Conventional Syringe<br>* Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.<br>Device: STA Single Tooth Anesthesia® System.<br>* Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale of pain perception by Wong-Baker FACES Pain Rating scale | The primary outcome was evaluated using Wong-Baker FACES Pain Rating scale. The child was briefly explained about each face and then asked to select the face that best described their feelings during the administration of local anesthesia. The scale consists of 6 cartoon faces depicting varying facial expressions, ranging from a very happy face (score 0) to a very sad one (score 10). | Up to 12 weeks. | 
| scale of pain perception by Sounds, eyes, and motor (SEM) scale. | The primary outcome was evaluated using Sounds, eyes, and motor (SEM) scale. These responses are categorized on a scale ranging from 1-4 categories comfort, mild discomfort, moderately painful, and painful. Two pediatric dentists who are blind to injection devises will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. | Up to 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain perception, Inferior Alveolar Nerve, Infiltration, Local Anesthesia, STA Single Tooth Anesthesia® System, Star Pen anesthesia device, Conventional syringe