Viewing Study NCT06461143



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06461143
Status: RECRUITING
Last Update Posted: 2024-06-27
First Post: 2024-06-04

Brief Title: Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
Sponsor: Istanbul University
Organization: Istanbul University

Study Overview

Official Title: Evaluation of the Efficacy of Computerized Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
Status: RECRUITING
Status Verified Date: 2024-09
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 goal of this clinical trial is to compare in effectiveness of intraosseous anesthesia and inferior alveolar block anesthesia in children with molar incisor hypomineralization MIH The main question it aims to answer are

- Is intraosseous anesthesia is more effective in pain control when restoring teeth with MIH
Detailed Description: The anxiety experienced by pediatric patients is one of the biggest problems that dentists encounter in practice and is closely related to their current oral health Studies have shown that dental anxiety depends on many factors but the pain that is thought to occur during the procedure is one of the most important reasons for the formation of dental anxiety Painful dental procedures cause anxiety and anxiety prolongs the duration and increases the severity of the pain felt For this reason coping with dentist anxiety at an early age and practices that will enable painless dental treatment in pediatric patients should be emphasized Behavioral guidance techniques and pain management are used to minimize the pain felt during dental treatment

Various strategies devices or techniques have been developed to reduce or eliminate pain occurring during local anesthesia injection Intraosseous injection is an anesthesia with a high success rate Anesthesia begins in a short time following the injection it does not cause numbness in the tongue-lips-cheek there is almost no injection pain and less anesthetic solution is used compared to traditional nerve block techniques

Situations that cause dental anxiety in pediatric patients include children with hypersensitive teeth Molar incisor hypomineralization MIH is a qualitative developmental enamel defect affecting at least one permanent molar The color of these defects can vary from white to yellow and brown and especially in severe cases enamel destruction may occur after application MIH dental hypersensitivity is among the most complicated cases that require management of various clinical difficulties in pediatric dentistry such as failure to provide adequate analgesiaanesthesia increased risk of carious lesion formation increased dental anxiety and increased aesthetic anxiety

MIH continues to be a subject that continues to be researched in pediatric dentistry Pediatric dentists encounter difficulties in providing adequate depth of anesthesia in restorative treatments especially in MIH accompanied by hypersensitivity This thesis study aims to examine the effect of intraosseous anesthesia on procedural pain in patients with MIH

As a result of the literature review the following hypothesis was put forward There is no significant difference in terms of pain perception between intraosseous anesthesia and traditional metal syringe anesthesia in children with MIH

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?: None
Is an FDA AA801 Violation?: None