Comparison of a Needle-free Local Anesthetic Technique With Traditional Syringe [ Needle Syringe] Technique for the Restoration of Permanent Molars

Child Behaviour Clinical Trial

Official title:

Effectiveness of a Needle-free Local Anesthetic Technique Compared to the Traditional Syringe Technique for the Restoration of Young Permanent Molars: A Single-blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06448507
• Other study ID #: Jazan University
• Status: Completed
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: University of Jazan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system [Traditional syringe system] for restoration of young permanent teeth. The main questions it aims to answer are:

1. To evaluate pain perception for restoration of young permanent tooth with a needle free system in a pediatric population.

2. To evaluate pain perception for restoration of young permanent tooth with needle syringe [Traditional syringe system] method in a pediatric population

3. Time required to deliver anesthesia using needle free system vs Needle syringe [ traditional syringe system]

Participants who enrolled in the study will be anesthetized according to the respective groups i,e needle free system and traditional dental needle system and restoration will be done.

Description:

Before the start of the study a written informed consent and ascent was obtained from each parent of the children included in the study stating they accepted the treatment. Ethical clearance will be obtained before the start of the study. Patients reporting to the dental clinics, college of dentistry will be included in the study.

Sample size estimation:

the sample size was estimated to be twenty-one (21). Twenty percent of the estimated sample size was added to compensate for sampling loss if any, thus the final sample size accounted to a total of twenty-five (25) participants in each group.

study design: It was a single blinded randomized controlled trial

Randomization:

Children will be allocated into one of the following two groups using a simple randomization method with a random number table, employing the sequentially numbered opaque sealed envelopes method of allocation concealment.

Group I: All participants in this group were subjected to the traditional needle syringe system. Local infiltration of Scandicaine 2% Speciale [Mepivacaine Hydrochloride and adrenaline] was administered using a traditional needle syringe equipped with a 27-gauge needle.

Group II: Participants in this group received the needle-free injection system, specifically the INJEX (Injex Pharma AG, Germany) 0.3ml of 2% Scandicaine will be adminsitered.

Intervention procedure

To avoid any operator-related bias, a single operator will manage the entire anesthesia protocol for all participants in the trial. Employing the "tell-show-do" technique, all relevant treatment equipment and protocols were introduced and explained to the participants. The injection process was fully described using appropriate euphemisms. Before administering the injection, the treatment area at the injection site was cleansed using a sterile dry gauze, and a small amount of topical anesthetic (Benzocaine 20%, NJ, USA) was applied, remaining in place for at least one minute. Following the application of topical anesthesia, local anesthesia was administered based on the participant's assigned group. After a standard waiting period of three minutes for the onset of anesthesia, dental caries was removed, dycal applied and final restoration with composite was done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children aged 7 - 14 years

• Existence of deep carious Permanent molar, indicated for Indirect pup capping.

• Complete physical and mental health without any confounding medical history

• Parents who gave written informed consent

Exclusion Criteria:

• Children below 7 years of age

• Children complaining of irreversible pulpitis.

• Children with Negative behaviour according to the wright's modification of Frankl

• Behaviour Rating scale (FBRS) during initial examination

• Children with medical or mentally compromised

Related Conditions & MeSH terms

• Child Behaviour

Intervention

Device:
• INJEX [Needle less anesthesia]
already described
• Syringe Needle [ Traditional technique]
described

Locations

Country	Name	City	State
Saudi Arabia	College of Dentistry	Jazan

Sponsors (1)

Lead Sponsor	Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children	FLACC assessment. FLACC gives an observational pain scale during the delivery of anesthesia	during and immediately after the delivery of anesthesia
Primary	Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children	Wong Baker Scale. Used to self-assess and effectively communicate the severity of pain they may be experiencing	During and immediately after the delivery of anesthesia
Secondary	Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children	FBRS	before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia
Secondary	Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children	Pulse rate	Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia
Secondary	Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children	time of local anesthesia administration	during the delivery of anesthesia