Clinical trial

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

Name
24-AKD-97
Description
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?
Trial arms
Trial start
2024-06-24
Estimated PCD
2025-06-23
Trial end
2025-11-24
Status
Not yet recruiting
Treatment
(%4 articaine with 1:200 000 adrenaline
For intraosseous anesthesia SleeperOne5 device is going to be used.
Arms:
Inferior alveolar nerve block, Intraosseous anesthesia
Size
80
Primary endpoint
Wong-Baker FACES Pain Rating Scale
Before and after local analgesia administration
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), * 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: -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Intraosseous anesthesia (n=40) Group 2: lnferior alveolar nerve block (n=40)\n\nIndividuals suitable for split-mouth design will be assigned to the opposite anesthesia arm, and their second teeth will be treated and measured.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-06-14

1 organization

1 product

2 indications