Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340022
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-18
Brief Title:
Pain and Anxiety Levels of Sleeperone Electronic Anesthesia System in Pediatric Patients
Sponsor:
Eskisehir Osmangazi University
Organization:
Eskisehir Osmangazi University
Study Overview
Official Title:
Comparison of Pain and Anxiety Levels of Sleeperone 5 Electronic Anesthesia System and Conventional Local Anesthesia Techniques in Pediatric Patients a Randomised Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The conventional method used for dental anesthesia in children is the administration of a local anesthetic solution by injection Although this process successfully eliminates pain during the procedure it continues to be a problem for many children in terms of dental anxiety before and during anesthesia administration
The aim of this study is to compare intraosseous anesthesia with SleeperOne 5 a computer-assisted local anesthesia system with conventional local anesthesia techniques in terms of pain and anxiety
The aim of this study is to compare intraosseous anesthesia with SleeperOne 5 a computer-assisted local anesthesia system with conventional local anesthesia techniques in terms of pain and anxiety
Detailed Description:
In the conventional injection technique painful local swelling of the tissues at the injection site occurs during the administration of local anesthetics Failure to control the rate of administration of anesthesia increases pain swelling and tissue tension leading to the discomfort and unpleasant sensations that accompany local anesthesia In addition an uncontrolled and shocking increase in pressure in the anesthetized tissues can lead to short-term blood supply disturbances and local damage reducing the effectiveness of anesthesia and increasing the risk of side effects It has been reported that the pain felt during anesthesia is mostly caused by the inability to control the pressure generated during the injection of the solution To overcome these shortcomings the search for new alternative and minimally invasive methods of local anesthesia has been in the limelight with better pain control reduced injection pain and improved quality of treatment for pedodontic procedures With the use of computer-assisted local anesthesia systems the anesthetic solution is administered gradually and the tissue pressure during anesthesia can be controlled Thus a less painful and more comfortable anesthesia experience can be provided SleeperOne 5 one of the computer-assisted local anesthesia systems is a device with advantages such as ease of use less intimidating physical appearance of the needle no need for pressure during injection guided entry points to the injection site There are no previous studies comparing the use of intraosseous technique with SleeperOne 5 device and conventional mandibular anesthesia in mandibular permanent molars In this study the investigators aimed to compare the pain and anxiety caused by the SleeperOne 5 anesthesia system in children compared to traditional anesthesia methods of which there are few studies in the literature The first null hypothesis H0 of the study is that there is no difference between intraosseous anesthesia administered with SleeperOne 5 computer-assisted anesthesia systems and buccal infiltration and mandibular anesthesia administered with conventional methods in terms of anxiety in patients The second null hypothesis of the study is that there is no difference between intraosseous anesthesia performed with SleeperOne 5 computer-assisted anesthesia systems and buccal infiltration and mandibular anesthesia performed with conventional methods in terms of pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None