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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Molar Hypomineralization
• Intervention / Treatment: Other: intraosseus anesthesia; Other: Conventional nerve block

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raghad Nassar, BDS; Phone Number: 01001717301; Email: raghadnassarr96@gmail.com

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt
      • Contact: Faculty of Dentistry; Phone Number: (203) 4868308
      • Principal Investigator: Raghad Nassar, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraosseous	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.
Active Comparator: Conventional nerve block	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local anesthesia efficacy	The Efficacy of local anesthesia to complete the restorative procedure successfully without pain will be evaluated by Efficacy Scale	throughout the procedure
change in child anxiety	It will be assessed using Venham Clinical Anxiety Scale (VCAS)	throughout the procedure

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Estimated): November 28, 2025
• Primary Completion (Estimated): January 20, 2026
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Molar Hypomineralization
• Other Study ID Numbers: 1109-07/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No