Skip to content

Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization

Effectiveness of Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07239050
Enrollment
26
Registered
2025-11-20
Start date
2025-11-28
Completion date
2026-01-20
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Hypomineralization

Brief summary

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

OTHERintraosseus 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.

OTHERConventional 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).

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in objective pain reactionthroughout the procedurePain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale The scale has five criteria, each assigned a score of 0, 1 or 2 (zero means no pain and 2 means severe pain). The total score scale is scored in a range of 0-10 with 0 representing no pain
Change in subjective pain scoresthroughout the procedureIt will be done by the child using Wong-Baker Faces Pain Rating Scale that ranged from 0 to 5. zero means no pain and 5 means pain is severe

Secondary

MeasureTime frameDescription
Local anesthesia efficacythroughout the procedureThe Efficacy of local anesthesia to complete the restorative procedure successfully without pain will be evaluated by Efficacy Scale
change in child anxietythroughout the procedureIt will be assessed using Venham Clinical Anxiety Scale (VCAS)

Countries

Egypt

Contacts

Primary ContactRaghad Nassar, BDS
raghadnassarr96@gmail.com01001717301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026