SleeperOne® 5 Intraosseous Anesthesia in MIH (CCLAD-MIH)
Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial
Přehled studie
Postavení
Podmínky
Detailní popis
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.
Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.
The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.
The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.
The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ankara, Turecko (Türkiye), 06560
- Ankara University Faculty of Dentistry
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children aged 8 to 14 years.
- Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
- MIH diagnosed according to EAPD criteria.
- Positive or definitely positive Frankl Behavior Rating Scale.
- Parent or guardian provided written informed consent.
Exclusion Criteria:
- Acute pulpal or periapical pathology.
- Developmental dental anomalies other than MIH.
- Allergy to local anesthetic agents.
- Medical contraindication to local anesthesia.
- Analgesic or anti-inflammatory drug use within 24 hours before treatment.
- Cognitive or communication disorders affecting study assessments.
- Uncooperative behavior.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: SleeperOne® 5-Assisted Intraosseous Anesthesia
Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
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Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
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Aktivní komparátor: Conventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
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Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Perception During Anesthetic Administration
Časové okno: Immediately after completion of local anesthesia administration (T1)
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Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater pain intensity.
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Immediately after completion of local anesthesia administration (T1)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Behavioral Pain Response
Časové okno: Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
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Behavioral pain response assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale.
The FLACC Scale ranges from 0 to 10, with scores of 0 indicating no pain-related behavioral distress and scores of 10 indicating severe pain-related behavioral distress.
Higher scores indicate greater pain-related behavioral distress.
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Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
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Dental Anxiety
Časové okno: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Dental anxiety assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
The CFSS-DS score ranges from 15 to 75, with higher scores indicating greater dental anxiety.
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Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Pulse Rate
Časové okno: Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
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Physiological response assessed by pulse rate (beats per minute)
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Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
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Peripheral Oxygen Saturation (SpO₂)
Časové okno: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Physiological response assessed by peripheral oxygen saturation measured by pulse oximetry as a percentage (%).
Higher values indicate greater oxygen saturation.
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Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 36290600/57/2023
- TDK-2024-3458 (Jiné číslo grantu/financování: Scientific Research Projects Coordination Unit of Ankara University)
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