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Pain Perception Comparison of Computerized vs Conventional Injection Methods

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06129162
Enrollment
120
Registered
2023-11-13
Start date
2023-10-30
Completion date
2024-06-30
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia, Pain Perception

Keywords

Pain perception, Inferior Alveolar Nerve, Infiltration, Local Anesthesia, STA Single Tooth Anesthesia® System, Star Pen anesthesia device, Conventional syringe

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.

Interventions

Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.

DEVICESTA Single Tooth Anesthesia® System.

Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration.

DEVICEStar Pen anesthesia device.

Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Selected children will be divided randomly into 3 groups: * Control group (Group I). * STA group (Group II). * Star pen group (Group III).

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
scale of pain perception by Wong-Baker FACES Pain Rating scaleUp 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.

Countries

Egypt

Contacts

Primary ContactOsamah M Almekhlafi, Master
dr.osamah.sp@hotmail.com00201141630514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026