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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-7
SponsorShatha Musaad Alharthi

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Root resorption exceeding one-third of root length or signs of mobility.

Fractured roots

Ankylosed roots.

Active infection or pathosis at the injection site.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: A) Experimental Group (CC-ILA using Super Pen)Experimental treatment 1 intervention
Group B: B) Control Group (Conventional IANB Technique)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate

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.

Time frame
immediately after the procedure (within the same treatment visit)
2

Oxygen saturation

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.

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

Secondary outcomes

1

Objective Pain assessment

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.

Time frame
immediately after the procedure (within the same treatment visit).
2

Subjective Pain assessment

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.

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

Other outcomes

1

Adverse Event Assessment

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

Time frame
24 hours

Sponsors and contacts

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Shatha Musaad Alharthi

Lead sponsor

Alexandria University

Sponsor institution

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