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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Perception
• Intervention / Treatment: Device: Experimental Group (CC-ILA using Super Pen)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shatha M Alharthi, BDS; Phone Number: +966541077444; Email: shatha.al-harthi@hotmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University, Egypt
    • Contact: Shatha AlHarthi, BDS; Phone Number: +966 54 107 7444; Email: shatha.al-harthi@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A) Experimental Group (CC-ILA using Super Pen); A) Experimental Group (CC-ILA using Super Pen); CC-ILA will be administered with the Super Pen according to manufacturer instructions.; 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.24; 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.	Device: Experimental 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.
Active Comparator: B) Control Group (Conventional IANB Technique); A 27-gauge 3 cm long needle will be used to administer Articaine 4% with 1:100,000 epinephrine via the standard IANB approach, followed by long buccal infiltration.; After negative aspiration, approximately 1.0 mL of solution will be delivered near the inferior alveolar nerve, and 0.5 mL as a buccal infiltration distal to the second primary molar.25; Anesthesia onset will be confirmed by gingival probing at 10-second intervals (CC-ILA) or 30-second intervals (IANB).	Device: Experimental 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	immediately after the procedure (within the same treatment visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	immediately after the procedure (within the same treatment visit).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Assessment	Parents will be questioned during the 24-hour follow-up regarding any unusual symptoms.	24 hours

Collaborators and Investigators

• Sponsor: Shatha Musaad Alharthi

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1208-12/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No