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Clinical Trials/NCT06461143
NCT06461143
Suspended
Not Applicable

Evaluation of the Efficacy of Computerized Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization

Istanbul University1 site in 1 country80 target enrollmentAugust 21, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Molar Incisor Hypomineralization
Sponsor
Istanbul University
Enrollment
80
Locations
1
Primary Endpoint
Wong-Baker FACES Pain Rating Scale
Status
Suspended
Last Updated
8 months ago

Overview

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 hypersensitive 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 analgesia/anesthesia, 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 cases of MIH type 3 and type 4 accompanied by hypersensitivity. This thesis study aims to examine the effect of intraosseous anesthesia on procedural pain in patients with MIH who have hypersensitivity problems. 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.

Registry
clinicaltrials.gov
Start Date
August 21, 2024
End Date
May 24, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yelda Kasımoğlu

Assoc. Prof.

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • Individuals applying the Department of Pedodontics, Istanbul University Faculty of Dentistry,
  • Systemically healthy,
  • Without any allergies,
  • Having at least one mandibular first molar with molar incisor hypomineralization (MIH),
  • Treatment need index 2 and 4,
  • Having a radiographically advanced decay lesion involving dentin (outer ½),
  • Possessing sufficient cooperation skills (Frankl scale 3 and 4),
  • Between the ages of 6-8,
  • Both male and female volunteers will be included.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Wong-Baker FACES Pain Rating Scale

Time Frame: To be measured 2 times on the day of treatment: 1. After local anesthesia application 2. After restoration

Patient-reported pain. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."

Secondary Outcomes

  • Frankl behaviour rating scale(To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. During local anesthesia 3. During whole treatment)
  • Pulse rate(To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration)
  • Blood pressure(To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration)
  • MCDAS(f) Turkish version(To be measured 2 times on the day of treatment: 1. In the waiting room before treatment 2. After treatment)

Study Sites (1)

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