Evaluating the Effectiveness of Intraosseous Anesthesia During Restorative Procedures on Teeth Affected by Molar Incisive Hypomineralization in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Analgesia
研究概览
简要总结
Managing MIH-affected teeth is challenging due to inflammation, sensitivity, rapid caries development, and difficulty achieving anesthesia.
This study aims to compare the effectiveness of intraosseous and conventional anesthesia in providing analgesia during restorations of MIH-affected molars in children aged 6-14.
Using a split-mouth model, each child will receive both anesthesia types on different molars, with conventional anesthesia as the control.
The study will assess the effectiveness of intraosseous anesthesia in achieving analgesia and reducing anxiety, helping dentists choose the best anesthesia technique.
详细描述
Introduction. Molar-incisor hypomineralization (MIH) is a qualitative defect in the development of the enamel that affects at least one first permanent molar (FPM), often also impacting permanent incisors. Although MIH is considered to be an idiopathic condition, its concise etiology remains unclear. The porous nature of MIH enamel and the presence of post-eruptive enamel breakdown leads to hypersensitivity and pain, which is often the patient's main complaint and can affect the quality of life. There is also the increased risk of dental fear and anxiety.
Dental anaesthesia, because it is mainly associated with pain, is one of the most important factors related to fear and discomfort in children and adolescents. The delivery of local anaesthetic solutions and the puncturing the mucosa by the needle during traditional infiltration procedures can be uncomfortable in spite of topical anaesthesia and computerized systems to deliver the anaesthetic at a constant rate and pressure. Infiltration methods (buccal infiltration, mandibular nerve block, etc.) may also be associated with mucosal numbing and self-biting of soft-tissues.
Clinical management of young patients with MIH-affected teeth becomes challenging due to chronic subclinical inflammation caused by ingress of bacteria in the exposed dentin, sensitivity and rapid caries development in the affected teeth, difficulty in achieving local anesthesia as a result of altered nerve potential, and limited cooperation of the young child due to hypersensitivity-related apprehension.
In the case of MIH, clinicians might be tempted to give a greater than usual dose of anesthetic to overcompensate for the hyper-reactive tooth. Treating a pediatric population limits anesthetic administration by weight and age, so the practitioner may reach the maximum dose before the desired anesthetic effect is achieved. An alternative anesthesia technique, which has been more widely used in endodontics, is the intraosseous injection.
Intraosseous (IO) injections consist of injecting local anaesthetic directly in the cancellous bone adjacent to any tooth to be anaesthetised. Since the anesthetic solution is targeted directly to the tooth requiring treatment, the surrounding soft tissues are usually not affected. Unlike other IO injections, Quicksleeper (Dental Hi-Tec, Cholet France) is a computer-controlled anesthetic system. Because there is an array of carriers and needles which serve a variety of different purposes, it is possible to administer IO injection (transcortical, osteocentral), periodontal ligament injection (PLE), intraseptal injections, infiltration, and nerve block anesthetics in this system. Owing to its asymmetric triple bevel, the needle tip makes possible a painless and easy perforation into the bone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of molar-incisor hypomineralization (MIH)
- •At least two first permanent molars affected by MIH
- •No prior dental procedures on those molars
- •Mentally and physically healthy
- •Cooperative behavior (Frankl score 3 or 4)
- •No use of analgesics in the 48 hours prior to treatment
排除标准
- •Periodontal changes (e.g., periodontal pockets, tooth mobility)
- •Radiographic bone loss, furcation involvement, or periapical radiolucency
研究组 & 干预措施
Intraosseous Anesthesia
Restorative dental treatment of MIH-affected teeth performed under intraosseous local anesthesia.
干预措施: Intraosseous anesthesia. (Device)
Conventional Local Anesthesia
Restorative dental treatment of MIH-affected teeth performed under conventional local infiltration anesthesia.
干预措施: Local infiltration anesthesia (Device)
结局指标
主要结局
Analgesia
时间窗: During procedure and immediately after, and 2 weeks postoperatively
The primary objective is to compare the effectiveness of intraosseous anesthesia versus conventional local anesthesia in achieving analgesia during restorative procedures on MIH-affected first permanent molars in children aged 6 to 14 years. Each tooth will be assigned a score according to this scale by another trained dentist at the end of each procedure: 0 = anesthesia insufficient; treatment could not be completed 1. = treatment completed with no pain or sensitivity 2. = treatment completed with mild sensitivity 3. = assessment could not be performed
次要结局
- Intraoperative pain(FIS and VAS scales- before and immediately after anesthesia. Objective assessment of pain during anesthetic administration. The heart rate will be measured before and during the application of anesthesia, and during the restaurative treatment.)
- Amount of anesthetic solution(Periprocedural)
- Duration of anesthetic application(Periprocedural, during administration of local anesthesia)
- Postoperative complications(3 weeks)
- Evaluation of GIC fillings(At the 3-month post-treatment control visit)
研究者
Kristina Gorseta
Professor
University of Zagreb
