Comparative evaluation of management of dental pain and anxiety during Indirect Pulp Capping procedure in MIH affected first permanent molars in pediatric patients aged 7-10 years with and without nitrous oxide oxygen sedation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Molar incisor hypomineralization (MIH)–affected first permanent molars often present with hypersensitivity and exaggerated pain responses, making routine restorative procedures such as indirect pulp capping challenging in pediatric patients. Increased dental anxiety and reduced cooperation in children aged 7–10 years can compromise effective pain control and treatment outcomes. Nitrous oxide–oxygen inhalation sedation is widely used in pediatric dentistry for its anxiolytic and analgesic properties, yet evidence comparing its effectiveness with conventional behavior management during MIH-related procedures is limited. Therefore, evaluating dental pain and anxiety during indirect pulp capping with and without nitrous oxide sedation is clinically relevant for optimizing MIH management in children.A prospective, comparative, two-arm randomized controlled clinical trial was conducted on 30 children diagnosed with MIH and requiring indirect pulp therapy between 7-10 years of age with or without nitrous oxide oxygen sedation. After initial examination, the children were divided into Group A (Control group- IPC without nitrous oxide sedation) and Group B (Test group- IPC with nitrous oxide sedation). Anxiety levels were evaluated by recording the pulse rate and the Facial Image Scale (FIS) before the procedure and during caries excavation and Dental pain was evaluated during caries excavation using the Visual Analogue Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •• First permanent molars affected by MIH requiring Indirect pulp capping procedure as per radiograph • Children exhibiting Frankel’s behaviour rating 3 or 4 • Children aged between 7-10 years • Vital pulp with no fistula or abscess, no history of continuous pain and absence of clinical and radiographic signs of pulp necrosis (internal and external root resorption, movement of the tooth, and swelling) • Based on –
- •Clinical examination
- •Symptoms of the patient
- •Radiographic examination.
排除标准
- •The presence of any systemic disease Any potential confounding enamel defects like amelogenesis imperfecta Uncooperative children according to Frankel’s scale (scale 1 and 2) Children with special health care needs A history of allergic reactions to local anaesthetics or some components of the materials used Children with upper respiratory tract infections Any recent middle ear disturbances or infections Children undergoing treatment with bleomycin sulphate Untreated cobalamin (vitamin B12) deficiency.
研究者
DR SHILPA S NAIK
Dr D Y Patil School of Dentistry , Deemed to be University