Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes

Not Applicable

Not yet recruiting

• Conditions: Early Childhood Caries
• Interventions: Device: Traditional metal Syringes; Device: dentapen

• Registration Number: NCT05959642
• Lead Sponsor: Cairo University

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

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 Timeline

• Study First Submitted: 2023-05-17
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-07-25
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Study Start: 2024-01-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional metal Syringes	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
Controlled Flow Delivery Dentapen	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

Primary Outcome Measures

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

Secondary Outcome Measures

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