Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization

August 5, 2025 updated by: Yelda Kasımoğlu, Istanbul University

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

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?

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University, Faculty of Dentistry, Department of Pedodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraosseous anesthesia
Computerized intraosseous anesthesia will be applied to the mandibular first molars of 40 patients.
Drug: %4 articaine with 1:200 000 adrenaline
For intraosseous anesthesia SleeperOne5 device is going to be used.
Active Comparator: Inferior alveolar nerve block
Conventional inferior alveolar block anesthesia will be applied to the mandibular first molars of 40 patients.
Drug: %4 articaine with 1:200 000 adrenaline
For intraosseous anesthesia SleeperOne5 device is going to be used.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frankl behaviour rating scale
Time Frame: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. During local anesthesia 3. During whole treatment
Behaviour assessment. The Frankl scale is an ordinal scale with 4 ratings used to describe a child's behavior from definitely negative (1), negative (2), positive (3), and definitely positive (4).
To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. During local anesthesia 3. During whole treatment
Pulse rate
Time Frame: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration
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
Time Frame: 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
Time Frame: To be measured 2 times on the day of treatment: 1. In the waiting room before treatment 2. After treatment
Dental anxiety. Scores on the MCDAS(f) scale may range from 8 to 40, with scores below 19 indicating absence of state anxiety, scores higher than 19 indicating the pres- ence of state anxiety and scores higher than 31, in- dicating severe phobic disorder.
To be measured 2 times on the day of treatment: 1. In the waiting room before treatment 2. After treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

April 24, 2026

Study Completion (Estimated)

May 24, 2026

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-AKD-97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Can be shared upon the request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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