CompletedNot Applicable

Pain Perception of Needle-free System

Turkey (Türkiye)56 participantsStarted 2019-03-11

Plain-language summary

The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments

Who can participate

Age range

4 Years – 11 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: * Aged between 4-11 years * Having no developmental or systemic disorder or no history of allergy * Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale * Having sufficient mouth opening * Operation only on primary teeth * Having decayed teeth that require anesthesia Exclusion Criteria: * Patients younger than five years, older than 11 years, * Patients with systemic or developmental disorders * Children with an allergy history * 'Negative' or 'definitly negative' behavior rating according to the Frankl scale * Patients whose mouth opening is not sufficient for dental treatment * Operating only on permanent teeth * Teeth that are beyond the treatment stage * When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.

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

Pain at different anesthesia methods

Timeframe: after dental treatments to 24 hour

Trial details

NCT IDNCT04653974

SponsorTokat Gaziosmanpasa University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-05

View on ClinicalTrials.gov More Pain trials

Who can participate

Age range

4 Years – 11 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.