Overview

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

Status:
Recruiting
Trial end date:
2021-12-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Sao Paulo
Treatments:
Ibuprofen
Criteria
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.