The Effect of Needle-free Injection System on Dental Injection Pain in Children

Summary

The aim of this study was to compare paediatric patients' pain perception and behavioural response during dental injection using needle free injection (NF) or traditional injection method (TM) over two consecutive visits.

Conditions

• Anesthesia, Local
• Child Behavior
• Pain

Interventions

DEVICE

Injection with the needle-free (NF) system

Before the injection procedure, the children were demonstrated the popping sound produced by device to prevent reflex reactions, and they informed that they would feel as if their gum were punched. The NF injection device was prepared according to the manufacturer's instructions, placed in full contact with the buccal mucosa and a pre-withdrawn dose of 0.1 ml was applied to the buccal region for topical purposes by the pushing the top of the device. After 10-15 seconds, the same procedure was repeated with withdrawn dose of 0.3 ml. After 5 min the treatment commenced, and the children were instructed to raise their hand if they experienced pain during the procedure. Each time the child indicated pain, in accordance with the same protocol an additional 0.3 ml of anesthetic solution was administered, until the sufficient anesthetic effect was obtained and the final amount of anesthetic solution were recorded. Precautions were taken to prevent tissue ballooning.

DEVICE

Injection with the traditional method (TM)

The depth of penetration was only a few millimeters and 0.3ml of anesthetic solution was deposited. After 5 min the treatment commenced, and the children were instructed to raise their hand if they experienced pain during the procedure. Each time the child indicated pain, in accordance with the same protocol an additional 0.3 ml of anesthetic solution was administered, until the sufficient anesthetic effect was obtained and the final amount of anesthetic solution were recorded. Precautions were taken to prevent tissue ballooning.

Sponsors & Collaborators

• Marmara University

  lead OTHER

Principal Investigators

• Sertaç Peker, Prof. · Marmara University, School of Dentistry, Istanbul/Turkiye

• Betül Kargül, Prof. · Marmara University, School of Dentistry, Istanbul/Turkiye

• Figen Eren, Assoc. Prof · Marmara University, School of Dentistry, Istanbul/Turkiye

• Gülnaz Nural Bekiroğlu, Prof. · Marmara University, School of Medicine, Istanbul/Turkiye

• Emrah Gökay Özgür, Asst. Prof. · Marmara University, School of Medicine, Istanbul/Turkiye

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-10

Primary Completion

2017-10-10

Completion

2018-04-10

Countries

• Turkey (Türkiye)

Study Locations