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

N/ANot Yet RecruitingNCT07575035

Shatha Musaad Alharthi30 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pain Perception

Interventions

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

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.

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

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

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).

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).

Central Contacts

Shatha M Alharthi, BDS

CONTACT

+966541077444 shatha.al-harthi@hotmail.com

Data from ClinicalTrials.gov

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