Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient pain perception
研究概览
简要总结
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
详细描述
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
Children aged 4-9 years old presenting with occlusal or proximal carious lesions of primary molars radiographically extending into the inner third or quarter of dentin will be invited to participate in this study. Patients will be randomized into two treatment groups using online block randomization technique (block of 6) and sealed envelope techniques. Time taken for clinical procedure will be recorded by a research assistant prospectively from the time the child sits on the dental chair till the end of procedure. Child pain perception will be recorded during intervention by a blinded research assistant using the Sound Eye Motor scale (SEM). Parental preference and child acceptance for each procedure will be recorded immediately after treatment using parent and child questionnaires. 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
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fit and healthy.
- •Occlusal or proximal carious lesions on primary molars radiographically extending into the inner third or quarter of dentin.
- •Vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
- •No tenderness to percussion, or pathological mobility.
- •No radiographic evidence of interradicular/ periapical radiolucency.
- •Radiographic evidence of a radiopaque dentin layer between the radiolucent caries lesion and the dental pulp
- •Tooth is restorable.
- •Patient has good level of cooperation for the intended procedure.
- •Parents consented for their children to be included in the study.
排除标准
- •Medically compromised children.
- •Irreversible pulpitis or pulp necrosis.
- •Soft and/or hard tissue pathology.
- •Furcal/ periapical pathology.
- •Root resorption exceeding one third of the root.
- •Pathological mobility.
- •Patient has poor level of cooperation for the intended procedure
结局指标
主要结局
Patient pain perception
时间窗: Perioperatively
will be evaluated by an observer (research assistant who will be trained, calibrated, and blinded to the treatment used) and recorded using the Sound, Eyes, and motor scale (SEM);Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort.
Rate of Radiographic Success
时间窗: 6,12 months
Absence of radiographic pathology in the root and the bone in the inter-radicular area.
Child acceptance of treatment
时间窗: immediately following intervention
Self-reported child acceptance using questionnaire
Parent acceptance of treatment
时间窗: immediately following intervention
Parental acceptance using questionnaire
Rate of Clinical Success
时间窗: 3,6,12 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
- Time taken for intervention(Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.)