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EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS

No phase Interventional Pain Perception

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental Group (CC-ILA using Super Pen).
Who it may be relevant to
Registry conditions: Pain Perception. Basic parameters: 5 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

EFFECT OF SUPER PEN COMPUTER-CONTROLLED INTRALIGAMENTARY INJECTION ON PAIN PERCEPTION IN PEDIATRIC PATIENTS UNDERGOING EXTRACTION OF PRIMARY MOLARS (RANDOMIZED CONTROLLED CLINICAL TRIAL)

Overview

The aim of this study to evaluate the effectiveness of CC-ILA using Super pen in eliminating pain during the extraction of mandibular primary molars, compared to the conventional Inferior Alveolar Nerve Block (IANB).

Interventions

  • Device Experimental Group (CC-ILA using Super Pen)
    * A standard 1.8 mL Articaine carpule will be used. The injection will be initiated at the distolingual line angle of the target tooth, with the needle inserted through the gingival sulcus at approximately a 30° angle to the long axis, bevel facing the alveolar bone. * Approximately 0.2 mL of 4% Articaine with 1:100,000 epinephrine will be delivered per root. * The visual pressure indicator will be monitored to ensure controlled delivery within optimal pressure ranges. Slight tissue blanching wi

Primary outcome measures

  • Heart rate [Time frame: immediately after the procedure (within the same treatment visit)]
  • Oxygen saturation [Time frame: immediately after the procedure (within the same treatment visit)]
Secondary outcome measures (2)
  • Objective Pain assessment [Time frame: immediately after the procedure (within the same treatment visit).]
  • Subjective Pain assessment [Time frame: immediately after the procedure (within the same treatment visit).]

Eligibility criteria

Inclusion criteria

  • Age 5-7 years.
  • Children free from systemic diseases or special healthcare needs (ASAI).14
  • No previous negative dental experiences.15
  • Positive or definitely positive preoperative behaviour, according to the Frankl Behaviour Rating Scale (scores 3 or 4) (Appendix I).16
  • Mandibular primary molars indicated for extraction.17,18
  • Parental consent to participate in the study.

Exclusion criteria

  • Root resorption exceeding one-third of root length or signs of mobility.
  • Fractured roots
  • Ankylosed roots.
  • Active infection or pathosis at the injection site.
  • History of allergy to local anesthetics.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Alexandria University, Egypt — Alexandria

Identifiers

NCT: NCT07575035 · 1208-12/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗