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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety
• Intervention / Treatment: Drug: Ibuprofen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Fernanda Vicioni-Marques, PhD Student; Phone Number: +55 16 3315-3995; Email: fernanda.vicioni.marques@usp.br

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14040-904
      • Recruiting
      • School of Dentistry of Ribeirão Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1:Ibuprofeno; 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.	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 Comparator: Group 2: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Director: Fabrício K de Carvalho, Professor, University of Sao Paulo, School of Dentistry of Ribeirão Preto

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): October 20, 2021
• Study Completion (Anticipated): December 20, 2021

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: AnalgesiaMIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No