RECRUITINGINTERVENTIONAL

Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

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.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient with molar incisor hypo-mineralization. 2. Patient's age ranges from 6 to 12 years old. 3. The affected tooth has demarcated opacity with post eruptive enamel breakdown. 4. No cavitated lesion is related to the defect of previous restorative or preventive treatment. Who Should NOT Join This Trial: 1. Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention. 2. Loss of tooth structure due to caries. 3. intolerance to ibuprofen. 4. developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patient with molar incisor hypo-mineralization. 2. Patient's age ranges from 6 to 12 years old. 3. The affected tooth has demarcated opacity with post eruptive enamel breakdown. 4. No cavitated lesion is related to the defect of previous restorative or preventive treatment. Exclusion Criteria: 1. Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention. 2. Loss of tooth structure due to caries. 3. intolerance to ibuprofen. 4. developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta.

Treatments Being Tested

DRUG

ibuprofen 100mg/ml oral suspension syrup

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.

DRUG

Placebo

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.

Locations (1)

October university of modern science and arts

Giza, Egypt