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NCT Number: NCT07239050

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

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

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Key information

Conditions

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

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location contact

Faculty of Dentistry

CONTACT

(203) 4868308

Raghad Nassar, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Change in objective pain reaction

    Time frame: throughout the procedure

    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

  2. Change in subjective pain scores

    Time frame: throughout the procedure

    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

Secondary outcomes

  1. Local anesthesia efficacy

    Time frame: throughout the procedure

    The Efficacy of local anesthesia to complete the restorative procedure successfully without pain will be evaluated by Efficacy Scale

  2. change in child anxiety

    Time frame: throughout the procedure

    It will be assessed using Venham Clinical Anxiety Scale (VCAS)

Study contacts

Contact information is provided by the study sponsor or research team.

Raghad Nassar, BDS

CONTACT

[email protected]

01001717301

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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