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

NCT07239050 | Not Yet Recruiting

• 1 other identifier: 1109-07/2025
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in objective pain reaction

  Pain 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

  throughout the procedure

• Change in subjective pain scores

  It 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

  throughout the procedure

Secondary Outcomes (2)

• Local anesthesia efficacy

  throughout the procedure

• change in child anxiety

  throughout the procedure

Study Arms (2)

Intraosseous

EXPERIMENTAL

Other: intraosseus anesthesia

Conventional nerve block

ACTIVE COMPARATOR

Other: Conventional nerve block

Interventions

intraosseus anesthesia 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.

Intraosseous

Conventional nerve block 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).

Conventional nerve block

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Raghad Nassar, BDS

CONTACT

01001717301; raghadnassarr96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 28, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

EG (1)