CompletedNot Applicable

The Effect of Needle-free Injection System During Palatal Anesthesia

Turkey (Türkiye)48 participantsStarted 2021-08-25

Plain-language summary

Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * In need of treatment of right and left primary molar teeth of maxilla, * 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 Exclusion Criteria: * No need for treatment of right and left primary molar teeth of maxilla, * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wong-Baker Faces Pain Rating Scale (PRS)

Timeframe: 3 months

Face, Legg, Cry, Consolability Scale (FLACC)

Timeframe: 3 months

Trial details

NCT IDNCT05166291

SponsorOkan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Pediatric Anesthesia trials