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

NCT ID: NCT07239050

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-28
• Study Completion Date: 2026-01-20

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

Conditions

Molar Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraosseous

Group Type: EXPERIMENTAL

intraosseus anesthesia

Intervention Type: OTHER

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.

Conventional nerve block

Group Type: ACTIVE_COMPARATOR

Conventional nerve block

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, Egypt

Countries

Egypt

Central Contacts

Raghad Nassar, BDS

Role: CONTACT

raghadnassarr96@gmail.com

01001717301

Facility Contacts

Faculty of Dentistry

Role: primary

(203) 4868308

Other Identifiers

1109-07/2025

Identifier Type: -

Identifier Source: org_study_id