Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, change in dental anxiety, and the requirement for supplemental local anaesthesia during restorative treatment.
详细描述
Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child.
Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was assessed using the Modified Child Dental Anxiety Scale immediately before local anaesthesia administration and immediately after completion of restorative treatment. The requirement for supplemental local anaesthesia during restorative treatment was recorded for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years.
- •Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria.
- •Presence of an MIH-affected permanent first molar classified as MIH-TNI Category 4a or 4b according to the updated Würzburg concept and requiring restorative treatment with either a direct resin composite restoration or a preformed stainless steel crown.
- •Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale.
- •No known allergy to local anaesthetics.
- •No relevant systemic disease.
排除标准
- •Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment.
- •Previous experience with intraosseous anaesthesia.
- •Presence of an acute dentoalveolar infection at the planned treatment site.
研究组 & 干预措施
Conventional Maxillary Infiltration Anaesthesia Group
Children in this arm received conventional supraperiosteal infiltration anaesthesia in the buccal sulcus adjacent to one MIH-affected maxillary permanent first molar before restorative treatment.
干预措施: Conventional Maxillary Infiltration Anaesthesia (Procedure)
Maxillary Digital Intraosseous Anaesthesia Group
Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the maxillary arch.
干预措施: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System (Device)
Conventional Mandibular Inferior Alveolar Nerve Block Group
Children in this arm received conventional inferior alveolar nerve block anaesthesia before restorative treatment of one MIH-affected mandibular permanent first molar.
干预措施: Conventional Inferior Alveolar Nerve Block Anaesthesia (Procedure)
Mandibular Digital Intraosseous Anesthesia Group
Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the mandibular arch.
干预措施: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System (Device)
结局指标
主要结局
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
时间窗: During the restorative procedure after local anesthesia administration, within the single treatment visit
Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
次要结局
- Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale(At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit)
- Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale(During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit)
- Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale(During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit)
- Change in Dental Anxiety From Before Local Anaesthesia to After Completion of Restorative Treatment Assessed Using the Modified Child Dental Anxiety Scale(Immediately before local anaesthetic administration and immediately after completion of restorative treatment, during the same treatment visit.)
- Requirement for Supplemental Local Anaesthesia During Restorative Treatment(During restorative treatment following administration of the allocated anaesthetic technique, within the same treatment visit.)