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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03953729
• Other study ID #: AnalgesiaMIH
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: September 2021
• Source: University of Sao Paulo
• Contact: Fernanda Vicioni-Marques, PhD Student
• Phone: +55 16 3315-3995
• Email: fernanda.vicioni.marques[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Dental Enamel Hypoplasia
• Pain

Intervention

Drug:
• Ibuprofen
The child and his / her guardian shall immediately upon arrival for informed about the participation in the research, being evaluated on the criteria of inclusion and exclusion described above. Soon after the signature by the responsible for the child of the Informed Consent Form (Appendix A), the drug shall be administered at the dosage established by Clark's formula, according to the weight of each child. It will then be evaluated the degree of anxiety of the child in front of the dental treatment using the scale "Children's Fear Survey Schedule-Dental Subscale" (Barberio, 2017). After 30 minutes of drug administration, treatment will start.
• Placebo
The child and his / her guardian shall immediately upon arrival for informed about the participation in the research, being evaluated on the criteria of inclusion and exclusion described above. Soon after the signature by the responsible for the child of the Informed Consent Form (Appendix A), the placebo shall be administered at the dosage established by Clark's formula, according to the weight of each child. It will then be evaluated the degree of anxiety of the child in front of the dental treatment using the scale "Children's Fear Survey Schedule-Dental Subscale" (Barberio, 2017). After 30 minutes of drug administration, treatment will start.

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirao Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Pain Scale	The child will indicate in the Wong Baker Face Scale what was the face associated with his/her pain. This scale consists of a visual observation by the child of several faces represented in drawing, ranging from 0 (no pain) to 10 (unbearable pain).	24 hours