Pain Perception
Conditions
Brief summary
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
DEVICEExperimental 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 will indicate adequate deposition. The procedure will be repeated at the mesiolingual line angle.
Sponsors
Shatha Musaad Alharthi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Single (participant)
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 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. |
| Oxygen saturation | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Pain assessment | 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. |
| Subjective Pain assessment | 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. |
Countries
Egypt
Contacts
CONTACTShatha M Alharthi, BDS
Outcome results
None listed