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

August 27, 2024 updated by: satish vishwanathaiah, University of Jazan

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

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 Primary and young permanent teeth. The main questions it aims to answer are:

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jazan, Saudi Arabia, 45142
        • College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 7 - 14 years
  • Existence of deep carious Primary and 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INJEX
needle less device
Device: INJEX [Needle less anesthesia]
already described
Active Comparator: Needle syringe
traditional dental needle
Device: Syringe Needle [ Traditional technique]
described

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children
Time Frame: during and immediately after the delivery of anesthesia
FLACC assessment. FLACC gives an observational pain scale during the delivery of anesthesia
during and immediately after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time Frame: During and immediately after the delivery of anesthesia
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time Frame: before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia
FBRS
before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time Frame: Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia
Pulse rate
Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time Frame: during the delivery of anesthesia
time of local anesthesia administration
during the delivery of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jazan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Jazan University

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings