The Effect of Needle-free Injection System During Palatal Anesthesia

NCT ID: NCT05166291

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2021-12-05

Brief Summary

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Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.

Detailed Description

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Conditions

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Pediatric Anesthesia Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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traditional anesthesia (TA)

traditional anesthesia

Group Type EXPERIMENTAL

traditional anesthesia

Intervention Type OTHER

local anesthesia applyed with dental syringe

comfort-in injection system (CIS)

comfort-in injection system (CIS)

Group Type EXPERIMENTAL

Comfort-in injection system

Intervention Type DEVICE

local anesthesia applyed with comfort-in injection system

Interventions

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Comfort-in injection system

local anesthesia applyed with comfort-in injection system

Intervention Type DEVICE

traditional anesthesia

local anesthesia applyed with dental syringe

Intervention Type OTHER

Other Intervention Names

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dental syringe

Eligibility Criteria

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Inclusion Criteria

* In need of treatment of right and left primary molar teeth of maxilla,
* Does not have any systemic disorder,
* High level of communication that can provide logical answers to the questions we ask
* With parental consent,
* Volunteers who want to participate in the research
* 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria

* No need for treatment of right and left primary molar teeth of maxilla,
* Has a systemic condition
* Low level of communication that cannot provide reasonable answers to the questions we ask
* Without parental consent
* Do not want to participate voluntarily in the research
* Do not attend a check-in
* Patients not in the 6-12 age group
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Okan University

OTHER

Sponsor Role lead

Responsible Party

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Emine Kaya

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Okan University Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E.617498811-000-1065232

Identifier Type: -

Identifier Source: org_study_id

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