Pain Perception Comparison of Computerized vs Conventional Injection Methods

Not Applicable

Recruiting

• Conditions: Pain Perception; Local Anesthesia
• Interventions: Device: STA Single Tooth Anesthesia® System.; Device: Conventional Syringe; Device: Star Pen anesthesia device.

• Registration Number: NCT06129162
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-20
• Study Start: 2023-10-30
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Apparently healthy children (5-8) years old, and free from systemic diseases.
2. Children who require local anesthetic injection for any dental treatment.
3. Cooperative children (positive or definitely positive on Frankel's scale).
4. Children who have no contraindications to the usage of selected local anesthetic agents.

Exclusion Criteria

• All that does not correspond to inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I: Control Group	STA Single Tooth Anesthesia® System.	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.
Group II: STA group	Conventional Syringe	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.
Group II: STA group	Star Pen anesthesia device.	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.
Group I: Control Group	Star Pen anesthesia device.	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.
Group III: Star pen group	STA Single Tooth Anesthesia® System.	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.
Group III: Star pen group	Conventional Syringe	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.

Primary Outcome Measures

Name	Time	Method
scale of pain perception by Wong-Baker FACES Pain Rating scale	Up to 12 weeks.	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).
scale of pain perception by Sounds, eyes, and motor (SEM) scale.	Up to 12 weeks.	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.

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Mansoura, Dakahlia, Egypt