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

August 2, 2024 updated by: Marmara University

The Effect of Needle-free Injection System on Dental Injection Pain in Children: A Cross-over, Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pain is a complex and multidimensional construct that involves sensory, emotional, and cognitive processes. One of the most important part of child behaviour guidance is pain control, and the most common method used to achieve pain control in dental procedures is using local anesthetics(LA). Nevertheless, administering a LA injection is among the most anxiety-provoking procedure for both children and adults patients in dentistry. Knowledge about change in pain related behaviour during consecutive visits helps in and scheduling of treatment procedures and management of children in dental clinic .

Thus, numerious methods and techniques have been suggested to minimize/reduce pain due to infiltration of LA agents, including application of topical anesthesia , pre-cooling injection site , pressure administration to injection site , applying laser as pretreatment method , warming and buffering the local anesthetics, tactile stimulations , distraction technique, use of narrow needles and slow delivery of the injection solution, computerized injection systems , employing modern devices such VibraJect , DentalVibe, or Aculief have been tried out to allay the fears of child patients. However none of them gained universal acceptance and more situations and techniques need to be evaluated to improve stress management among patients in dental settings.

During the administration of a LA injection, an anxious patient might perceive more severe pain of longer duration than would a less anxious patient. Visually and psychologyically, the dental syringe is perceived as a threatening instrument, especially by children. Fear of pain from 'the needle' has been frequently indicated to be the most fear-evoking stimulus for dentally anxious children.

The needle- free injection system may yield a higher level of comfort, because it involves no puncture or injection phase and has emerged as a novel alternative to traditional needle- based techniques. The Comfort-inTM system (Mika Medical; Busan, Korea) is a recent dental device that uses a needle-free injection technique to administer local anesthesia. This system is a patented device using the "liquid jet" system to inject the anesthetic solution rapidly from a 0.15-mm hole with high pressure. The use of this needle-free local anaesthesia system in dentistry can be of a help in treating needle phobia patients. To the extent of investigators knowledge, there were few studies have evaluated the effectiveness of this new injection technique on primary molars in children. Investigators feel that paediatric patients are the target group for whom pain control should be adequately followed. Therefore, the current study was designed to compare paediatric patients' pain perception during dental injection using new needle-free injection system (NF) or traditional injection method (TM). In addition, secondary outcomes such as dosage of local anesthetics used (ml) and duration of the analgesia effect (min) were assessed. The expectation and tested hypotheses were that the needle-free method would produce lower pain injection and lower dosage of local anesthetics during the dental procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Injection with the needle-free (NF) system
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
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.
Active Comparator: Injection with the traditional method (TM)
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wong-Baker Faces Pain Rating Scale (WB PRS) (Wong DL, 1988)
Time Frame: 12 Month
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)
Time Frame: 12 Month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of Anesthetic Solution (ml)
Time Frame: 12 month
Total amount of used anesthetic solution
12 month
Duration of the Analgesia Effect (min)
Time Frame: 12 month
Duration of used anesthetic solution
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sertaç Peker, Prof., Marmara University, School of Dentistry, Istanbul/Turkiye
  • Principal Investigator: Betül Kargül, Prof., Marmara University, School of Dentistry, Istanbul/Turkiye
  • Study Chair: Figen Eren, Assoc. Prof, Marmara University, School of Dentistry, Istanbul/Turkiye
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU_DHF_DPD_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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