Anesthesia, LocalNCT06541925
The Effect of Needle-free Injection System on Dental Injection Pain in Children
A study testing Injection with the needle-free (NF) system and Injection with the traditional method (TM) in people with Anesthesia, Local and Child Behavior, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Child Behavior, Pain
- What is being tested?
- Injection with the needle-free (NF) system and Injection with the traditional method (TM)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2017to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Local, Child Behavior, Pain
- Being tested
- Injection with the needle-free (NF) system, Injection with the traditional method (TM)
- Medical subject headings
- Child Behavior, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection with the needle-free (NF) systemDevice
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Injection with the traditional method (TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Month
Secondary outcomes (2)
Amount of Anesthetic Solution (ml)
Total amount of used anesthetic solution
Measured: 12 month
Duration of the Analgesia Effect (min)
Duration of used anesthetic solution
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start10 Apr 2017
- Primary completion10 Oct 2017
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sertaç Peker, Prof., Principal investigator, Marmara University, School of Dentistry, Istanbul/TurkiyeBetül Kargül, Prof., Principal investigator, Marmara University, School of Dentistry, Istanbul/TurkiyeFigen Eren, Assoc. Prof, Study chair, Marmara University, School of Dentistry, Istanbul/TurkiyeGülnaz Nural Bekiroğlu, Prof., Principal investigator, Marmara University, School of Medicine, Istanbul/TurkiyeEmrah Gökay Özgür, Asst. Prof., Principal investigator, Marmara University, School of Medicine, Istanbul/Turkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541925
- Sponsor's protocol ID
- MU_DHF_DPD_01
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Needle-free Injection System on Dental Injection Pain in Children: A Cross-over, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06541925
- Acronym / sponsor ID
- MU_DHF_DPD_01
- Conditions
- Anesthesia, Local, Child Behavior, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection with the needle-free (NF) system | Experimental | Device: Injection with the needle-free (NF) systemThe 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. |
| Injection with the traditional method (TM) | Active comparator | Device: 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection with the needle-free (NF) systemBefore 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 needle-free (NF) system |
| 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. | Device | Injection with the traditional method (TM) |
Primary outcome
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.
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.
2 secondary outcomes
Amount of Anesthetic Solution (ml)
Time frame: 12 month
Duration of the Analgesia Effect (min)
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sertaç Peker, Prof. principal investigator
Marmara University, School of Dentistry, Istanbul/Turkiye
Betül Kargül, Prof. principal investigator
Marmara University, School of Dentistry, Istanbul/Turkiye
Figen Eren, Assoc. Prof study chair
Marmara University, School of Dentistry, Istanbul/Turkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection with the needle-free (NF) system and Injection with the traditional method (TM) in people with Anesthesia, Local and Child Behavior, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Faces Pain Rating Scale (WB PRS) (Wong DL, 1988) (time frame: 12 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.