Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization

NCT ID: NCT06461143

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2026-05-24

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 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 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.

Conditions

Molar Incisor Hypomineralization; Hypersensitivity; Composite Restoration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraosseous anesthesia

Computerized intraosseous anesthesia will be applied to the mandibular first molars of 40 patients.

Group Type: EXPERIMENTAL

%4 articaine with 1:200 000 adrenaline

Intervention Type: DRUG

For intraosseous anesthesia SleeperOne5 device is going to be used.

Inferior alveolar nerve block

Conventional inferior alveolar block anesthesia will be applied to the mandibular first molars of 40 patients.

Group Type: ACTIVE_COMPARATOR

%4 articaine with 1:200 000 adrenaline

Intervention Type: DRUG

For intraosseous anesthesia SleeperOne5 device is going to be used.

Interventions

%4 articaine with 1:200 000 adrenaline

For intraosseous anesthesia SleeperOne5 device is going to be used.

Intervention Type: DRUG

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

-

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Yelda Kasımoğlu

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University, Faculty of Dentistry, Department of Pedodontics

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

24-AKD-97

Identifier Type: -

Identifier Source: org_study_id