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

NCT06541925 | Completed

• 1 other identifier: MU_DHF_DPD_01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Faces Pain Rating Scale (WB PRS) (Wong DL, 1988)

  which measures the unpleasantness or affective dimension of a child's pain experience. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, 'no hurt') to 5 (crying/screaming face, 'hurts worst'). This scale was explained to the children carefully in advance. Immediately after the each injection, the children were asked to rate the level of pain perceived during the administration, using the PRS.

  12 Month

• Face, Legs, Activity, Cry, Consolability (FLACC) Scale. (Merkel SI, 1997)

  Pain level also objectively evaluated by the operator using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. (Merkel SI, 1997) This scale includes the following points: face, leg, activity, cry and consolability. Each one of these five categories records either 0, 1, or 2 which result in either a minimum degree of 0 or a maximum degree of 10. According to this scale: 0 = quiet and relaxed (no pain), 1-3 = mild discomfort or pain, 4-6 = moderate pain, and 7-10 = severe pain.

  12 Month

Secondary Outcomes (2)

• Amount of Anesthetic Solution (ml)

  12 month

• Duration of the Analgesia Effect (min)

  12 month

Study Arms (2)

Injection with the needle-free (NF) system

EXPERIMENTAL

The device used for needle free system was Comfort-in™ (Mika Medical Global Co, Busan, Korea) anesthesia device. The Comfort-in™ system, has a micro-hole injection needle (0.15 mm) that injects the anesthetic solution under the mucosa. The pressure can be controlled according to the dose of the drug to be used, thereby reduced the pain that may occur with the needle in the injection.

Device: Injection with the needle-free (NF) system

Injection with the traditional method (TM)

ACTIVE COMPARATOR

The TM was used with traditional syringe on the opposite side of the dental arch. The injection site was dried with a cotton-tip applicator, and topical anesthetic spray (Lidocaine 10%, Vemcain, Turkey) was applied to the injection area with cotton-tip for 1-2 min. The traditional injection was performed with a 26-gauge, 40-mm, disposable syringe with a needle (Genject, Turkey). The depth of penetration was only a few millimeters and 0.3ml of anesthetic solution was deposited.

Device: Injection with the traditional method (TM)

Interventions

Injection with the needle-free (NF) system DEVICE

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.

Injection with the needle-free (NF) system

Injection with the traditional method (TM) DEVICE

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.

Injection with the traditional method (TM)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with good general health without any history of allergic reactions as determined by a written history;
• Not currently taking any analgesics or sedative medication that would alter their pain perception
• Children demonstrated either 'positive' or 'definitely positive' behavior according to the Frankl Behavior Scale (FBS)
• Requiring treatment on their maxillary primary molars bilaterally with similar operative difficulties.

You may not qualify if:

• The existence of medical or developmental situations, history of chronic disease
• 'negative' or 'definitely negative' behavior rating according to the Frankl Behavior Scale (FBS)
• The presence of inflammation at the injection site.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child Behavior; Pain

Interventions

Injections; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sertaç Peker, Prof.

  Marmara University, School of Dentistry, Istanbul/Turkiye

  PRINCIPAL INVESTIGATOR

• Betül Kargül, Prof.

  Marmara University, School of Dentistry, Istanbul/Turkiye

  PRINCIPAL INVESTIGATOR

• Figen Eren, Assoc. Prof

  Marmara University, School of Dentistry, Istanbul/Turkiye

  STUDY CHAIR

• Gülnaz Nural Bekiroğlu, Prof.

  Marmara University, School of Medicine, Istanbul/Turkiye

  PRINCIPAL INVESTIGATOR

• Emrah Gökay Özgür, Asst. Prof.

  Marmara University, School of Medicine, Istanbul/Turkiye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: August 7, 2024
• Study Start: April 10, 2017
• Primary Completion: October 10, 2017
• Study Completion: April 10, 2018
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

TU (1)