Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes

Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes on Pain Perception During the Administration of Anesthesia Among A Group of Pediatric Dental Patients: A Split-Mouth Randomized Clinical Trial

This study compares the effect of the controlled flow delivery Dentapen® technique to traditional syringes on pain perception during dental procedures among a group of pediatric dental patients

Study Overview

• Status: Not yet recruiting
• Conditions: Early Childhood Caries
• Intervention / Treatment: Device: dentapen; Device: Traditional metal Syringes

Detailed Description

Local anesthetic injections are usually the main reason for fear and anxiety during dental treatment. Pain management is a critical aspect of pediatric dental care. Fear associated with seeing and experiencing needle penetration, sensation of swelling soft tissues and prolonged numbness as well as allergic reactions to the anesthetic fluid, are the most common factors causing patients and dental clinicians to experience anxiety regarding the use of infiltration local anesthesia. Exploring new alternative and a traumatic method will help improving the quality of care in pediatric dentistry.

Consequently, there is a constant search for new techniques looking to avoid the invasive and often painful nature of the anaesthetic injection required for dental treatments, making it a more pleasant and less distressing experience for patients.

Even though there are no techniques available that can totally replace conventional local anaesthesia, some alternatives have been developed that are effective in a limited range of procedures. In 1997, a new method for the administration of anaesthetics was launched: the computer- controlled local anaesthesia delivery system (CCLADS). After

2006, the single tooth anaesthesia system (STA) (Milestone Scientific, Inc. Livingston, NJ, USA) was also introduced.

Currently, one of the most discouraging aspects for many patients undergoing dental procedures is the administration of anaesthesia. Consequently, there is a constant search for new techniques to avoid the invasive and painful nature of the injection. A new, cableless, motorised syringe system (Dentapen®) has recently been developed, standing out for its convenience and ease of use. The slow injection of anaesthetics at low pressure appears to reduce pain and discomfort during dental anaesthesia, and that currently does not require specific training. It has several injection settings, allowing it to be held like a syringe or pen, and is compatible with all anaesthetic needles and cartridges from all brands with an accurate control of flow and pressure of the injection can therefore mitigate the pain experienced by these patients.

So, the purpose of the current study was to evaluate the effect of controlled flow delivery Dentapen® technique on pain perception among a group of pediatric dental patients in comparison to conventional injection technique.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham Salman Alshakhs; Phone Number: 00966599928825; Email: rehamsalman23@gmail.com
• Study Contact Backup: Name: Prof. Dr. Sherif Salman Bahgat; Phone Number: 00966599928823; Email: rehamsalman23@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged between 6 and 8 years

  • Healthy children with no systemic problems.
  • Cooperative Children
  • First dental visit
  • Children willing to provide assent and parent willing to provide informed consent
  • Bilaterally decayed primary maxillary first molars with normal radiographic findings and need restorative treatment

Exclusion Criteria:

Children with previously restored teeth

• Children requiring emergency dental treatment (cellulitis, abscess)
• Children's teeth with signs or symptoms of Pulpitis
• Children whose parents refuse to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Controlled Flow Delivery Dentapen; Controlled Flow Delivery Dentapen - infiltration upper d according to the manufacturer instructions it works with standardised 1.8 ml local anaesthetic carpules . 1)we raise the lip a little 2) we use dentapen for anaesthesia 3) class 1 cavity preparation Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected.The dentist will wait 5 seconds	Device: dentapen; Experimental: Controlled Flow Delivery Dentapen according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted upper D teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle
Active Comparator: Traditional metal Syringes; Traditional metal Syringes we raise the lip a little 2) infiltration upper d we use traditional syringes 3)class 1 cavity preparation with composit filling works with standardised 1.8 ml local anaesthetic carpules . we use Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected.The dentist will wait 5 seconds	Device: Traditional metal Syringes; Active Comparator: Conventional Injection of infiltration upper d a standard technique for the Injection of infiltration upper d will be used supplemented with long buccal infiltration for the buccal gingiva. A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed to primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception during injection of local anesthesia	Wong-Baker faces pain rating scale; Scores (0-10)	in the same visit after finishing the procedure, 0 scale - no pain , 10 scale -worest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate during injection of local anesthesia	measured by Pulse oximeter, Beats per minute (BPM)	in the same visit after finishing the procedure

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Carvajal-Nunez U, Prieur D, Vitova T, Somers J. Charge distribution and local structure of americium-bearing thorium oxide solid solutions. Inorg Chem. 2012 Nov 5;51(21):11762-8. doi: 10.1021/ic301709d. Epub 2012 Oct 16.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: non invasive technique
• Other Study ID Numbers: Denta pen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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