Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intraosseus anesthesia, Conventional nerve block.
- Who it may be relevant to
- Registry conditions: Molar Hypomineralization. Basic parameters: 6 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial)
Overview
Background: Effective pain control is crucial in managing pediatric dental patients. Molar-incisor hypomineralization (MIH), marked by enamel defects and dentin hypersensitivity, often hinders effective local anesthesia. Traditional injection methods may fall short, causing discomfort and complicating treatment. Combining infiltration with intraosseous injection using an extra-short 31-G needle may offer a more effective alternative. Purpose: To compare the effectiveness of combined infiltration and intraosseous injection with an extra-short 31-G needle versus conventional techniques in eliminating pain during
Interventions
- Other intraosseus anesthesia
MIH-affected hypersensitive deeply carious FPM extending into the inner 1/3 of the dentin mandibular FPM allocated to be anesthesized using infiltration followed by intraosseus anesthesia using extra-short 31-G needle. - Other Conventional nerve block
MIH affected hypersensitive deeply carious FPM extending into the inner 1/3 of the dentin mandibular FPM allocated to be anesthesized using long 30-G needle (IANB) and short 30-G short needle (buccal infiltration).
Primary outcome measures
- Change in objective pain reaction [Time frame: throughout the procedure]
- Change in subjective pain scores [Time frame: throughout the procedure]
Secondary outcome measures (2)
- Local anesthesia efficacy [Time frame: throughout the procedure]
- change in child anxiety [Time frame: throughout the procedure]
Eligibility criteria
Inclusion criteria
- Healthy children, American Society of Anesthesiologists class I, II
- Cooperative children during preoperative assessments according to the Frankl'
- Behavioral Rating Scale (scores 3 or 4)
- Patient presenting with at least one hypersensitive SCASS 2,3 \[22\] (Appendix III) deeply carious, MIH-affected FPM, with caries extending to the inner third of the dentin and close to the pulp, as shown in the periapical radiograph, consistent with TNI 4c classification for MIH
- Written consent of the legal guardian.
Exclusion criteria
- Any physical or mental disability or psychological problems.
- Immunocompromised patients.
- Hypersensitivity to local anesthetic drugs used.
- Taking analgesics or other medications that alter the child's behavior or awareness of pain 12- hours pre-operatively
- Patients requiring emergency treatment.
- FPM with preoperative signs and symptoms of clinical failure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt — Alexandria
Identifiers
NCT: NCT07239050 · 1109-07/2025