Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461143
• Other study ID #: 24-AKD-97
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 24, 2024
• Est. completion date: November 24, 2025

Study information

• Verified date: June 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 24, 2025
• Est. primary completion date: June 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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),

• Experiencing hypersensitivity (type 3 and type 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:

-

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Drug:
• (%4 articaine with 1:200 000 adrenaline
For intraosseous anesthesia SleeperOne5 device is going to be used.

Locations

Country	Name	City	State
Turkey	Istanbul University, Faculty of Dentistry, Department of Pedodontics	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wong-Baker FACES Pain Rating Scale	Patient-reported pain	Before and after local analgesia administration
Secondary	Frankl behaviour rating scale	Behaviour assessment	Behaviour at the time of initial examination and during local analgesia administration
Secondary	Pulse rate	Pulse rate	Before and during local analgesia administration
Secondary	Blood pressure	Blood pressure	Before and during local analgesia administration
Secondary	MCDAS(f) Turkish version	Dental anxiety	Before and after local analgesia administration