Effect of Starpen CCLAD in Injection and Extraction

NCT06827223 | Not Yet Recruiting

• 1 other identifier: Starpen CCLAD in injection
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars.

Conditions

Pain Assessment

Keywords

Starpen CCLADS

Outcome Measures

Primary Outcomes (1)

• Subjective Pain perception during injection of local anesthesia

  After injection, the child will be asked to choose a face from the Wong-Baker faces pain rating scale to express his pain experience after explaining the scale to him (Scores from 0 to 10),The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"

  immediately after the procedure(injection)

Secondary Outcomes (5)

• objective pain perception during local anesthesia injection

  During the procedure (injection)

• Subjective pain perception during the extraction

  immediately after the procedure(extraction)

• objective pain perception during extraction

  During the procedure (extraction)

• Physiological parameter (heart rate)

  at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)

• Physiological parameter (oxygen saturation)

  at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)

Study Arms (2)

control group

ACTIVE COMPARATOR

nerve block anesthesia and extraction of mandibular primary molars using a Traditional Syringe

Device: Traditional Syringe

intervention group

EXPERIMENTAL

nerve block anesthesia and extraction of mandibular primary molars using Computer-controlled Starpen Automatic Injection Device

Device: computer-controlled Starpen Automatic Injection Device

Interventions

computer-controlled Starpen Automatic Injection Device DEVICE

using computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars

intervention group

Traditional Syringe DEVICE

nerve block anesthesia and extraction of mandibular primary molars using Traditional Syringe

control group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-8 years
• Cooperative children (Rating 3 or 4 based on the Frankl behavior scale)
• Medically fit children (ASA I).
• Children are mentally capable of communication.
• First dental visit.
• Patient requiring extraction of lower primary molars due to root caries, crown fractures, periapical disease, and failed pulpotomies.

You may not qualify if:

• Children with a behavioral management problem.
• Parental refusal of participation.
• Children with a previous history of local anesthesia injection.
• Medically unfit children (other than ASA I).
• Uncooperative children (other than Frankl 3,4).
• Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
• Teeth that showed any signs of mobility, ankylosis, or root resorption affecting more than one-third of the root

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• Saoji H, Nainan MT, Nanjappa N, Khairnar MR, Hishikar M, Jadhav V. Assessment of computer-controlled local anesthetic delivery system for pain control during restorative procedures: A randomized controlled trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):298-304. doi: 10.15171/joddd.2019.045.

  PMID: 32190214 BACKGROUND

• Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P. Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.

  PMID: 30143396 BACKGROUND

• Attia S, Austermann T, May A, Mekhemar M, Conrad J, Knitschke M, Bottger S, Howaldt HP, Riad A. Pain perception following computer-controlled versus conventional dental anesthesia: randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):425. doi: 10.1186/s12903-022-02454-1.

  PMID: 36138388 BACKGROUND

• Janik K, Niemczyk W, Peterek R, Roj R, Balicz A, Morawiec T. Computer-Controlled Local Anaesthesia Delivery efficacy - a literature review. Saudi Dent J. 2024 Aug;36(8):1066-1071. doi: 10.1016/j.sdentj.2024.05.012. Epub 2024 May 31.

  PMID: 39176166 BACKGROUND

• Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.

  PMID: 26156269 BACKGROUND

• Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.

  PMID: 38239164 BACKGROUND

Central Study Contacts

Sara M Soliman, Bachelor's degree 2020

CONTACT

00201009740402; sara.masoud@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 14, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02