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 volunteersQualifiers
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
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
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
Other outcomes
Adverse Event Assessment
Parents will be questioned during the 24-hour follow-up regarding any unusual symptoms.
Sponsors and contacts
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Shatha Musaad Alharthi
Lead sponsor
Alexandria University
Sponsor institution
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