Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes

NCT05959642 | Unknown

• 1 other identifier: Denta pen
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Early Childhood Caries

Keywords

non invasive technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart rate during injection of local anesthesia

  in the same visit after finishing the procedure

Study Arms (2)

Controlled Flow Delivery Dentapen

EXPERIMENTAL

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

Traditional metal Syringes

ACTIVE COMPARATOR

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

Interventions

dentapen DEVICE

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

Controlled Flow Delivery Dentapen

Traditional metal Syringes DEVICE

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

Traditional metal Syringes

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 23072315 BACKGROUND

Central Study Contacts

Reham Salman Alshakhs

CONTACT

00966599928825; rehamsalman23@gmail.com

Prof. Dr. Sherif Salman Bahgat

CONTACT

00966599928823; rehamsalman23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Student

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: July 25, 2023
• Study Start: January 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share