Preemptive Analgesia for Pain and Anxiety Control in Children With MIH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorOctober University for Modern Sciences and Arts
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
ibuprofen 100mg/ml oral suspension syrup
Drugibuprofen 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.
Placebo
Drugthe 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: ibuprofen 100mg/ml oral suspension syrupExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
during injection and during procedureSecondary outcomes
1
pain perception (subjective)
Wong Baker FACES Pain Rating Scale. It consists of several faces ranging from happy (0) to crying (10).
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)2
dental anxiety
pulse oximeter (heart rate monitor) unit: Beat/ minute
Time frame
initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)3
dental anxiety
pulse oximeter oxygen saturation unit: percentage
Time frame
initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)Sponsors and contacts
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Source ClinicalTrials.gov