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

Pain Clinical Trial

Official title:
Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH): Triple-blind Clinal Study, Randomized and Controlled by Placebo

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03953729
Study type Interventional
Source University of Sao Paulo
Contact Fernanda Vicioni-Marques, PhD Student
Phone +55 16 3315-3995
Email fernanda.vicioni.marques@usp.br
Status Recruiting
Phase Early Phase 1
Start date April 1, 2019
Completion date December 20, 2021
View Details
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