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The dentist who was taking care of the study's patients stopped working for a while because she went on maternity leave.
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraosseous anesthesia | Experimental | Computerized intraosseous anesthesia will be applied to the mandibular first molars of 40 patients. |
|
| Inferior alveolar nerve block | Active Comparator | Conventional inferior alveolar block anesthesia will be applied to the mandibular first molars of 40 patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| %4 articaine with 1:200 000 adrenaline | Drug | For intraosseous anesthesia SleeperOne5 device is going to be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frankl behaviour rating scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Faculty of Dentistry, Department of Pedodontics | Istanbul | Turkey (Türkiye) |
Can be shared upon the request.
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| D006967 | Hypersensitivity |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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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.
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| Pulse rate | 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 | 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 | 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 |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007154 | Immune System Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |