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

September 27, 2021 updated by: Vicioni-Marques, F, University of Sao Paulo

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Pain Scale
Time Frame: 24 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fabrício K de Carvalho, Professor, University of Sao Paulo, School of Dentistry of Ribeirão Preto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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