Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization

NCT06461143 | Suspended DMC

• 1 other identifier: 24-AKD-97
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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?

Conditions

Molar Incisor Hypomineralization; Hypersensitivity; Composite Restoration

Keywords

dental pain; dental anxiety

Outcome Measures

Primary Outcomes (1)

• Wong-Baker FACES Pain Rating Scale

  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 Outcomes (4)

• 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 Arms (2)

Intraosseous anesthesia

EXPERIMENTAL

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

Drug: %4 articaine with 1:200 000 adrenaline

Inferior alveolar nerve block

ACTIVE COMPARATOR

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

Drug: %4 articaine with 1:200 000 adrenaline

Interventions

%4 articaine with 1:200 000 adrenaline DRUG

For intraosseous anesthesia SleeperOne5 device is going to be used.

Inferior alveolar nerve block; Intraosseous anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Faculty of Dentistry, Department of Pedodontics

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization; Hypersensitivity; Toothache

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immune System Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Group 1: Intraosseous anesthesia (n=40) Group 2: lnferior alveolar nerve block (n=40) Individuals suitable for split-mouth design will be assigned to the opposite anesthesia arm, and their second teeth will be treated and measured.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: August 21, 2024
• Primary Completion: April 24, 2026
• Study Completion (Estimated): May 24, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

TU (1)