CompletedNot Applicable

Evaluation of Different Anesthesias in Children With Molar Incisor Hypomineralization

Turkey (Türkiye)28 participantsStarted 2024-02-05

Plain-language summary

In children with molar-incisor hypomineralization (MIH), insufficient depth of anesthesia can lead to increased anxiety and behavior management problems, which may negatively affect the quality of restorations. This situation has increased the need for modern techniques and devices to minimize pain during local anesthesia. The aim of this study was to compare the effects of the SleeperOne computer-controlled local anesthesia system and the conventional local anesthesia technique on pain and anxiety in children with MIH. The null hypothesis of the study stated that there would be no statistically significant difference between the effects of the two local anesthesia methods on pain and anxiety in children with MIH.

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: * Being between the ages of 6 and 12 * Not having a systemic disease * Frankl Behavior Rating Scale score of 3 or 4 * Presence of bilateral MIH in the lower or upper jaw permanent first molars * Deep dentinal caries in permanent 1st molars that can be treated with vital pulp treatments * No history of acute pain in the teeth planned to be included in the study Exclusion Criteria: * Having a systemic disease * Allergy to the anesthetic to be used * Having an acute infection * Unilateral teeth with BAKH lesions and deep dentin caries * If they or their parents do not want to participate in the study * The teeth planned to be included in the study showed irreversible pulpitis symptoms * Among the patients planned to be included in the study; those who did not consent to anesthesia or treatment, those who did not come to their second appointment, and those who needed devital pulp treatments during the procedure

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

Evaluation of the effect of different anesthesia on pain in teeth with MIH

Timeframe: 6 month

Evaluation of the effect of different anesthesia on anxiety in teeth with MIH

Timeframe: 6 month

Trial details

NCT IDNCT07268157

SponsorCanan Bayraktar Nahir

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-05

View on ClinicalTrials.gov More Molar-Incisor Hypomineralization trials