PainEarly Phase 1NCT03953729
Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH)
A Early Phase 1 study testing Ibuprofen in people with Pain and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
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". Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2019to 20 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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>)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
School of Dentistry of Ribeirao Preto
Ribeirão Preto, São Paulo, 14040-904
Fernanda Vicioni Marques, pHD Student, +55 16 999936791, fernanda.vicioni.marques@usp.br
Fabrício Kitazono de Carvalho, Professor Doctor
About this study
Official title: 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.
- Being tested
- Ibuprofen, Placebo
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Ibuprofeno | Experimental | 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. Receives: Drug: Ibuprofen |
| Group 2: Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Apr 2019
- Primary completion20 Oct 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicioni-Marques, F, University of Sao Paulo
- Investigators
- Fabrício K de Carvalho, Professor, Study director, University of Sao Paulo, School of Dentistry of Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953729
- Sponsor's protocol ID
- AnalgesiaMIH
- Status last verified
- Sep 2021
- First submitted
- 25 Apr 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH): Triple-blind Clinal Study, Randomized and Controlled by Placebo
- ClinicalTrials.gov ID
- NCT03953729
- Acronym / sponsor ID
- AnalgesiaMIH
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Oct 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Ibuprofeno | Experimental | Drug: IbuprofenThe 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. |
| Group 2: Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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>)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenThe 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 | Group 1:Ibuprofeno |
| PlaceboThe 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 | Group 2: Placebo |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrício K de Carvalho, Professor study director
University of Sao Paulo, School of Dentistry of Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ibuprofen in people with Pain and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Vicioni-Marques, PhD Student (+55 16 3315-3995, fernanda.vicioni.marques@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.