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

NCT07575035 | Not Yet Recruiting

• 1 other identifier: 1208-12/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain Perception

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Objective Pain assessment

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

• Subjective Pain assessment

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

Other Outcomes (1)

• Adverse Event Assessment

  24 hours

Study Arms (2)

A) Experimental Group (CC-ILA using Super Pen)

EXPERIMENTAL

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)

B) Control Group (Conventional IANB Technique)

ACTIVE COMPARATOR

* 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)

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.

A) Experimental Group (CC-ILA using Super Pen); B) Control Group (Conventional IANB Technique)

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shatha Musaad Alharthi: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

Central Study Contacts

Shatha M Alharthi, BDS

CONTACT

+966541077444; shatha.al-harthi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (participant)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc.research of pediatric dentistry

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

EG (1)