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NCT Number: NCT07575035

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

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).

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Key information

Conditions

Pain Perception

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Experimental Group (CC-ILA using Super Pen)

Device
  • 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 will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.

Primary outcomes

  1. Heart rate

    Time frame: immediately after the procedure (within the same treatment visit)

    Heart rate will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.

  2. Oxygen saturation

    Time frame: immediately after the procedure (within the same treatment visit)

    Oxygen saturation will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated.

Secondary outcomes

  1. Objective Pain assessment

    Time frame: immediately after the procedure (within the same treatment visit).

    Pain will be assessed using the Sound, Eye, and Motor (SEM) Scale. Each component will be graded from 1 (comfort) to 4 (severe discomfort) by the operator and the independent outcome assessor evaluator reviewing video recordings.

  2. Subjective Pain assessment

    Time frame: immediately after the procedure (within the same treatment visit).

    Pain perception will be recorded after anesthesia and Extraction using a modified facial expression scale. Children will choose from three schematic faces representing satisfaction, indifference, or dissatisfaction.

Other outcomes

  1. Adverse Event Assessment

    Time frame: 24 hours

    Parents will be questioned during the 24-hour follow-up regarding any unusual symptoms.

Study contacts

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

Shatha M Alharthi, BDS

CONTACT

[email protected]

+966541077444

Sponsors and collaborators

Lead sponsor

Shatha Musaad Alharthi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

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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