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

A

Alexandria University

Status

Not yet enrolling

Conditions

Molar Hypomineralization

Treatments

Other: intraosseus anesthesia
Other: Conventional nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT07239050
1109-07/2025

Details and patient eligibility

About

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

Enrollment

26 estimated patients

Sex

All

Ages

6 to 9 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Intraosseous
Experimental group
Treatment:
Other: intraosseus anesthesia
Conventional nerve block
Active Comparator group
Treatment:
Other: Conventional nerve block

Trial contacts and locations

1

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Central trial contact

Raghad Nassar, BDS

Data sourced from clinicaltrials.gov

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