UnknownEarly Phase 1

Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH)

Brazil50 participantsStarted 2019-04-01

Plain-language summary

Pain is defined by IASP (International Association for the Study of Pain) as "an unpleasant sensory and emotional experience associated with the damage actual or potential tissue or described in terms that suggest such harm". Episodes of pain and discomfort experienced by children are one of the main factors for fear and anxiety in dentistry, especially those that present the condition of Molar-Incisive Hipomineralization, where we observed increased levels of anxiety in relation to the treatment. In order to improve the painful sensation that patients with Molar-Incisor Hipomineralization present as well as anxiety demonstrated by these patients in face of dental treatment, the objective of present study will be to evaluate the occurrence and degree of pain after procedures dentists with administration of pre-emptive analgesia or placebo, in children with Molar-Incisive Hipomineralization. Fifty patients will be selected in the Pediatric Dentistry courses of the FORP-USP undergraduate course, aged 6 to 12 years, of both sexes, who present at least 2 (two) upper and / or lower molars affected by Molar- Incisors that need some kind of restorative treatment, extraction or endodontic treatment. Also, these patients should present enamel and dentin fractures caused by MIH, atypical restoration and / or atypical caries, and that present pain above the moderate degree (6\>), after stimulation with air/water jet for 5 seconds.

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: * present at least 2 (two) upper molars and/or lower affected by Molar-Incisor Hypomineralization * restorative treatment * extraction * endodontic treatment * pain above the moderate degree (6\>) Exclusion Criteria: * patients with suspected of analgesics of any type or presence of acute pain in the last 24 hours before the procedure * patient with history of hepatopathy * bleeding hemorrhagic disorders * hypersensitivity to components * patients and family members who do not have a telephone or that the children will not under parental supervision in the first 24 hours after care.

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

Visual Pain Scale

Timeframe: 24 hours

Trial details

NCT IDNCT03953729

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-20

Contact for this trial

Fernanda Vicioni-Marques, PhD Student

+55 16 3315-3995 fernanda.vicioni.marques@usp.br

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