Pediatric AnesthesiaanesthesiaNCT04028271
Local Anesthesia With Needle-free Injection System
A study testing Comfort-in injection system and conventional injection with dental needle in people with Pediatric Anesthesia and Local Anesthesia, run by Sinem yildirim at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Anesthesia, Local Anesthesia
- What is being tested?
- Comfort-in injection system and conventional injection with dental needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 15 Jun 2019
- 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
- In need of treatment of right and left molar teeth of mandible,
- Does not have any systemic disorder,
- High level of communication that can provide logical answers to the questions we ask
- With parental consent,
- Volunteers who want to participate in the research
- 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic
Who cannot join
- No need for treatment of right and left molar teeth of mandible,
- Has a systemic condition
- Low level of communication that cannot provide reasonable answers to the questions we ask
- Without parental consent
- Do not want to participate voluntarily in the research
- Do not attend a check-in
- Patients not in the 6-12 age group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okan University Faculty of Dentistry
Istanbul, 34959
About this study
Official title: Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth
The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).
- Conditions
- Pediatric Anesthesia, Local Anesthesia
- Being tested
- Comfort-in injection system, conventional injection with dental needle
- Keywords
- needle-free injection, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort-in injection systemDevice
local anesthesia during dental treatment
conventional injection with dental needleOther
for local anesthesia during dental treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | local anesthesia applyed with Comfort in system Receives: Device: Comfort-in injection system |
| conventional injection | Active comparator | local anesthesia applyed with conventional syringe Receives: Other: conventional injection with dental needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Rating Scale (PRS)
The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. 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").
Measured: 1 year
Face, Legg, Cry, Consolability Scale (FLACC)
The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Jun 2018
- Primary completion15 May 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinem yildirim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sinem yildirim, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028271
- Sponsor's protocol ID
- 2018/201
- Other IDs
- Marmara universty
- Acronym
- anesthesia
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth
- ClinicalTrials.gov ID
- NCT04028271
- Acronym / sponsor ID
- anesthesia / 2018/201
- Conditions
- Pediatric Anesthesia, Local Anesthesia
- Keywords
- needle-free injection, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sinem yildirimUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 22 Jul 2019 (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 purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Device: Comfort-in injection systemlocal anesthesia applyed with Comfort in system |
| conventional injection | Active comparator | Other: conventional injection with dental needlelocal anesthesia applyed with conventional syringe |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- In need of treatment of right and left molar teeth of mandible,
Key exclusion criteria (7 listed)
- No need for treatment of right and left molar teeth of mandible,
- Has a systemic condition
- Low level of communication that cannot provide reasonable answers to the questions we ask
- Without parental consent
- Do not want to participate voluntarily in the research
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 |
|---|---|---|
| Comfort-in injection systemlocal anesthesia during dental treatment | Device | experimental |
| conventional injection with dental needlefor local anesthesia during dental treatment | Other | conventional injection |
Primary outcome
Wong-Baker Faces Pain Rating Scale (PRS)
Time frame: 1 year
The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. 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").
Face, Legg, Cry, Consolability Scale (FLACC)
Time frame: 1 year
The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.
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 22 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort-in injection system and conventional injection with dental needle in people with Pediatric Anesthesia and Local Anesthesia, run by Sinem yildirim 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 6 inclusion and 7 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 22 Jul 2019. 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 (PRS) (time frame: 1 year). 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 22 Jul 2019.