CompletedNot Applicable

Comparison of a Needle-free Local Anesthetic Technique With Traditional Syringe [ Needle Syringe] Technique for the Restoration of Primary Molars and Permanent Molars

Saudi Arabia50 participantsStarted 2024-01-16

Plain-language summary

The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system \[Traditional syringe system\] for restoration of Primary and young permanent teeth. The main questions it aims to answer are: 1. To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population. 2. To evaluate pain perception for restoration of primary and young permanent tooth with needle syringe \[Traditional syringe system\] method in a pediatric population 3. Time required to deliver anesthesia using needle free system vs Needle syringe \[ traditional syringe system\] Participants who enrolled in the study will be anesthetized according to the respective groups i,e needle free system and traditional dental needle system and restoration will be done.

Who can participate

Age range

7 Years – 14 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: * Children aged 7 - 14 years * Existence of deep carious Primary and Permanent molar, indicated for Indirect pup capping. * Complete physical and mental health without any confounding medical history * Parents who gave written informed consent Exclusion Criteria: * Children below 7 years of age * Children complaining of irreversible pulpitis. * Children with Negative behaviour according to the wright's modification of Frankl * Behaviour Rating scale (FBRS) during initial examination * Children with medical or mentally compromised

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

Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children

Timeframe: during and immediately after the delivery of anesthesia

Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children

Timeframe: During and immediately after the delivery of anesthesia

Trial details

NCT IDNCT06448507

SponsorUniversity of Jazan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-03-30

View on ClinicalTrials.gov More Child Behaviour trials