Pain and Anxiety in Children With MIHNCT07374354
Preemptive Analgesia for Pain and Anxiety Control in Children With MIH
A study testing ibuprofen 100mg/ml oral suspension syrup in people with Pain and Anxiety in Children With MIH, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
This randomized, triple-blinded clinical trial aims to evaluate the effect of preemptive analgesia using ibuprofen on pain perception and anxiety during restorative treatment of first permanent molars in children diagnosed with molar-incisor hypomineralization (MIH). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain and Anxiety in Children With MIH
- What is being tested?
- ibuprofen 100mg/ml oral suspension syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- Patient with molar incisor hypo-mineralization.
- Patient's age ranges from 6 to 12 years old.
- The affected tooth has demarcated opacity with post eruptive enamel breakdown.
- No cavitated lesion is related to the defect of previous restorative or preventive treatment.
Who cannot join
- Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention.
- Loss of tooth structure due to caries.
- intolerance to ibuprofen.
- developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October university of modern science and arts
Giza, 12611
Esraa Diaaeldin Elhenie, bachelor, 00201094007206, ediaaeldin@msa.edu.eg
About this study
Official title: Assessment of Preemptive/Preoperative Analgesia Effect on Pain Perception and Anxiety Management in Children With Molar Incisor Hypo-Mineralization During Restorative Treatment of First Permanent Molar: A Triple-Blinded Randomized Clinical Trial.
This randomized, triple-blinded clinical trial aims to evaluate the effect of preemptive analgesia using ibuprofen on pain perception and anxiety during restorative treatment of first permanent molars in children diagnosed with molar-incisor hypomineralization (MIH). MIH-affected teeth often present with hypersensitivity, difficulty in achieving adequate anesthesia, and increased dental anxiety, which complicates dental treatment. Participants aged 6-12 years with MIH will receive either ibuprofen syrup or placebo 30 minutes before treatment. Pain will be assessed using the FLACC Behavioral Pain Scale and Wong-Baker FACES scale, and anxiety will be evaluated through heart rate and oxygen saturation. The results will determine whether preoperative ibuprofen reduces intraoperative pain and improves anxiety control in this population.
Read the detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect associated with post-eruptive breakdown, hypersensitivity, difficulty achieving effective anesthesia, increased dental anxiety, and a higher risk of restorative complications. Children with MIH require more frequent and complex dental care and often experience discomfort during treatment, negatively impacting their cooperation and oral-health-related quality of life.
Preemptive analgesia-the administration of analgesics before starting dental procedures-has shown promise in reducing nociceptive transmission and improving anesthetic efficacy. Previous studies have evaluated the effect of ibuprofen on pain during dental procedures in MIH-affected children, but evidence remains limited, and anxiety-related outcomes have not been comprehensively assessed.
This triple-blinded randomized controlled trial will include children aged 6-12 presenting with MIH and post-eruptive enamel breakdown but without carious lesions or prior restorations. Participants will be randomly assigned (1:1) to receive either ibuprofen 100 mg syrup or a matching placebo 30 minutes before treatment. All procedures will be performed under standardized conditions, including local anesthesia with articaine 4%, rubber dam isolation, and restorative treatment by trained pediatric dentists.
Pain perception will be recorded using both objective and subjective metrics. Objective pain will be evaluated using the FLACC Behavioral Pain Scale during anesthesia and treatment. Subjective pain will be assessed using the Wong-Baker FACES scale at predefined time points before, during, and after treatment. Dental anxiety will be monitored using physiological indicators: heart rate and oxygen saturation measured with a pulse oximeter at baseline, during, and after the dental procedure.
The primary objective is to determine whether preemptive ibuprofen reduces behavioral pain responses during treatment. Secondary objectives include assessing self-reported pain and physiologic anxiety measures. The findings aim to guide pediatric clinicians in improving pain control, reducing treatment-related anxiety, and enhancing the overall management of children with MIH.
- Conditions
- Pain and Anxiety in Children With MIH
- Being tested
- ibuprofen 100mg/ml oral suspension syrup, Placebo
- Keywords
- Molar Incisor Hypomineralization (MIH), Preemptive Analgesia, Ibuprofen, Dental Pain, Dental Anxiety, FLACC Scale, Wong-Baker FACES, Post-Eruptive Enamel Breakdown, Children 6-12 Years, Analgesic Efficacy
- Medical subject headings
- Pain, Molar Hypomineralization, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofen 100mg/ml oral suspension syrupDrug
ibuprofen 100 mg/ml oral suspension administration 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars.
PlaceboDrug
the placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration placebo will be 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars.
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen 100mg/ml oral suspension syrup | Experimental | The analgesic will be labeled A; (ibuprofen 100 mg/ml oral suspension). Administration of analgesic will be 30 mins prior to procedure.
The Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure.
Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000.
Rubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established. Receives: Drug: ibuprofen 100mg/ml oral suspension syrup |
| placebo | Placebo comparator | The placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration of placebo will be 30 mins prior to procedure.
The Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure.
Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000.
Rubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception (objective)
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: during injection and during procedure
Secondary outcomes (3)
pain perception (subjective)
Wong Baker FACES Pain Rating Scale. It consists of several faces ranging from happy (0) to crying (10).
Measured: Initial before procedure (baseline) After drug/placebo administration (30 min), Before anesthesia, After anesthesia, During the procedure (real-time) 24 hours after the end of the procedure (post-operative)
dental anxiety
pulse oximeter (heart rate monitor) unit: Beat/ minute
Measured: initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)
dental anxiety
pulse oximeter oxygen saturation unit: percentage
Measured: initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and Anxiety in Children With MIHStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Diaaeldin Nady Elhenie, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374354
- Sponsor's protocol ID
- Esraa MSA University
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Preemptive/Preoperative Analgesia Effect on Pain Perception and Anxiety Management in Children With Molar Incisor Hypo-Mineralization During Restorative Treatment of First Permanent Molar: A Triple-Blinded Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07374354
- Acronym / sponsor ID
- Esraa MSA University
- Conditions
- Pain and Anxiety in Children With MIH
- Keywords
- Molar Incisor Hypomineralization (MIH), Preemptive Analgesia, Ibuprofen, Dental Pain, Dental Anxiety, FLACC Scale, Wong-Baker FACES, Post-Eruptive Enamel Breakdown
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 Jan 2026 (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.
This randomized, triple-blinded clinical trial aims to evaluate the effect of preemptive analgesia using ibuprofen on pain perception and anxiety during restorative treatment of first permanent molars in children diagnosed with molar-incisor hypomineralization (MIH). MIH-affected teeth often present with hypersensitivity, difficulty in achieving adequate anesthesia, and increased dental anxiety, which complicates dental treatment. Participants aged 6-12 years with MIH will receive either ibuprofen syrup or placebo 30 minutes before treatment. Pain will be assessed using the FLACC Behavioral Pain Scale and Wong-Baker FACES scale, and anxiety will be evaluated through heart rate and oxygen saturation. The results will determine whether preoperative ibuprofen reduces intraoperative pain and improves anxiety control in this population.
Detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect associated with post-eruptive breakdown, hypersensitivity, difficulty achieving effective anesthesia, increased dental anxiety, and a higher risk of restorative complications. Children with MIH require more frequent and complex dental care and often experience discomfort during treatment, negatively impacting their cooperation and oral-health-related quality of life.
Preemptive analgesia-the administration of analgesics before starting dental procedures-has shown promise in reducing nociceptive transmission and improving anesthetic efficacy. Previous studies have evaluated the effect of ibuprofen on pain during dental procedures in MIH-affected children, but evidence remains limited, and anxiety-related outcomes have not been comprehensively assessed.
This triple-blinded randomized controlled trial will include children aged 6-12 presenting with MIH and post-eruptive enamel breakdown but without carious lesions or prior restorations. Participants will be randomly assigned (1:1) to receive either ibuprofen 100 mg syrup or a matching placebo 30 minutes before treatment. All procedures will be performed under standardized conditions, including local anesthesia with articaine 4%, rubber dam isolation, and restorative treatment by trained pediatric dentists.
Pain perception will be recorded using both objective and subjective metrics. Objective pain will be evaluated using the FLACC Behavioral Pain Scale during anesthesia and treatment. Subjective pain will be assessed using the Wong-Baker FACES scale at predefined time points before, during, and after treatment. Dental anxiety will be monitored using physiological indicators: heart rate and oxygen saturation measured with a pulse oximeter at baseline, during, and after the dental procedure.
The primary objective is to determine whether preemptive ibuprofen reduces behavioral pain responses during treatment. Secondary objectives include assessing self-reported pain and physiologic anxiety measures. The findings aim to guide pediatric clinicians in improving pain control, reducing treatment-related anxiety, and enhancing the overall management of children with MIH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen 100mg/ml oral suspension syrup | Experimental | Drug: ibuprofen 100mg/ml oral suspension syrupThe analgesic will be labeled A; (ibuprofen 100 mg/ml oral suspension). Administration of analgesic will be 30 mins prior to procedure. The Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure. Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000. Rubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established. |
| placebo | Placebo comparator | Drug: PlaceboThe placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration of placebo will be 30 mins prior to procedure. The Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure. Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000. Rubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient with molar incisor hypo-mineralization.
- Patient's age ranges from 6 to 12 years old.
- The affected tooth has demarcated opacity with post eruptive enamel breakdown.
- No cavitated lesion is related to the defect of previous restorative or preventive treatment.
Key exclusion criteria (4 listed)
- Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention.
- Loss of tooth structure due to caries.
- intolerance to ibuprofen.
- developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta.
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 |
|---|---|---|
| ibuprofen 100mg/ml oral suspension syrupibuprofen 100 mg/ml oral suspension administration 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars. | Drug | ibuprofen 100mg/ml oral suspension syrup |
| Placebothe placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration placebo will be 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars. | Drug | placebo |
Primary outcome
Pain perception (objective)
Time frame: during injection and during procedure
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
3 secondary outcomes
pain perception (subjective)
Time frame: Initial before procedure (baseline) After drug/placebo administration (30 min), Before anesthesia, After anesthesia, During the procedure (real-time) 24 hours after the end of the procedure (post-operative)
dental anxiety
Time frame: initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)
dental anxiety
Time frame: initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ibuprofen 100mg/ml oral suspension syrup in people with Pain and Anxiety in Children With MIH, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. 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 Egypt. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (objective) (time frame: during injection and during procedure). 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 Jan 2026.