Selective Versus Non-selective Caries Excavation in MIH Affected Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of Radiographic Success
研究概览
简要总结
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.
详细描述
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.Cases will be collected from the undergraduate and postgraduate clinics over a 6 months' period according to predetermined inclusion criteria. Preoperative clinical and radiographic assessment will be conducted to MIH affected molars. MIH molars with deep caries (assymptomatic/ with symptoms of reversible pulpitis) will be randomly allocated for the choice of treatment with selective or non -selective caries excavation. Randomization of teeth between the 2 treatment groups will be performed using an online block randomization technique (block of 6) with the tooth as unit of randomization. Time taken for each procedure will be recorded by the research assistant each visit prospectively after achieving local anaesthesia till the end of procedure. Patients will be asked to rate their satisfaction with the received treatment on the end of treatment visit using a designed questionnaire. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient age <13 years old
- •Non -contributory medical history
- •Molar affected with MIH as per EAPD diagnostic criteria (White, creamy, or yellow to brownish opacities greater than one millimeter with/without postoperative enamel breakdown).
- •Deep caries extending>= 2/3 of dentine but not exposing the pulp on the bitewing radiograph.
- •The tooth should give positive response to cold sensibility testing.
- •Clinical diagnosis of normal/ reversible pulpitis
- •The tooth is restorable, probing pocket depth and mobility are within normal limits.
- •No signs of pulpal necrosis including sinus tract or swelling
- •No radiographic evidence of periapical changes indicative of apical periodontitis.
排除标准
- •Medically compromised patient.
- •Non-restorable tooth.
- •Clinical diagnosis of irreversible pulpitis.
- •Signs of pulpal necrosis including sinus tract or swelling.
- •Teeth indicated for extraction for orthodontic reasons.
- •Uncooperative children who could not be treated under local anesthesia.
结局指标
主要结局
Rate of Radiographic Success
时间窗: 6,12 months
No radiographic evidence of periapical changes indicative of apical periodontitis
Rate of Clinical Success
时间窗: 6,12 months
Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
次要结局
- Patient acceptance of treatment(immediately following intervention, and at 6 and 12 months recall)
- Time taken for intervention(Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed.)
- Child pain score(preoperatively and one week following the intervention)