Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Successful
研究概览
简要总结
Dental caries, particularly in primary molars, significantly affects children's oral health and overall well-being. Traditional management with stainless steel crowns (SSCs) involves significant tooth reduction and advanced dental skills. Introduced in the 1970s, the Hall technique offers a less invasive alternative, minimizing tooth reduction compared to SSCs.
The SMART Hall technique represents a further evolution, emphasizing atraumatic cavity preparation using hand instruments. It offers advantages like minimal or no tooth reduction, minimized discomfort, improved patient cooperation, shorter treatment times, and cost-effectiveness.
Silver Diamine Fluoride (SDF) emerges as a promising non-invasive approach for managing dental caries in primary teeth, though it may cause temporary tooth discoloration. However, comparative evaluation with traditional SSC restorations remains limited.
To address this gap, a randomized clinical trial will evaluate the treatment outcomes of the SMART Hall technique versus conventional SSC restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of young patients. Children aged 3 to 9 years requiring restorations will be included, assessing clinical outcomes, treatment time duration, and radiographical outcomes of both techniques at specific follow-up intervals of 3 months & 6 months.
This split mouth study will explore Clinical outcomes, radiographical outcomes, treatment time duration, and patient's pain perception with the chosen treatment modality. The findings will provide insights into the effectiveness and feasibility of the SMART Hall technique compared to the traditional SSC approach, informing evidence-based decision-making in pediatric dentistry and influencing treatment recommendations for preserving the health and function of primary molars in young children.
详细描述
AIM OF THE STUDY The aim of this research study is to compare the treatment outcomes of the SMART Hall technique with conventional stainless steel crown (SSC) restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of 3- to 9-year-old children.
OBJECTIVES OF THE STUDY
- To evaluate and compare the clinical success rates of the SMART Hall technique and conventional SSC restoration in managing occluso-proximal carious lesions in primary molars over a follow-up period of 3 & 6 months.
- To evaluate and compare the treatment time duration of the SMART Hall technique and conventional SSC restoration in managing occluso-proximal carious lesions in primary molars.
- To assess and compare the survival rates of teeth restored using the SMART Hall technique and conventional SSC restoration over a follow-up period of 3 & 6 months.
- To assess and compare the radiographical outcomes of teeth restored using the SMART Hall technique and conventional SSC restoration over a follow-up period of 3 & 6 months.
- To analyze and compare patient-reported perceptions of treatment using a Visual Analogue Scale between the two treatment modalities.
INCLUSION CRITERIA
- Children aged 3 to 9 years old.
- Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
- Requirement for restorative treatment in the form of either the SMART Hall technique or conventional stainless steel crown (SSC) restoration, as determined by clinical assessment.
- Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
- Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants are masked to treatment allocation, while care providers and investigators are not. Outcomes assessors remain masked to minimize bias. The biostatistician is blinded to treatment modality to avoid bias in data analysis, with data labeled as "treatment modality 1" and "treatment modality 2" in the Excel sheet.
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3 to 9 years old.
- •Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
- •Requirement for restorative treatment in the form of either the SMART Hall technique or standard stainless steel crown (SSC) restoration, as determined by clinical assessment.
- •Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
- •Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.
排除标准
- •Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
- •Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants, unless medically managed and deemed safe by the treating healthcare provider.
- •History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
- •Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
- •Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.
结局指标
主要结局
Successful
时间窗: Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
1. Restoration Satisfactory: The restoration appears satisfactory upon clinical examination, with no visible defects or issues. \- No Intervention Required: The tooth does not require any additional intervention post-restoration. 2. Absence of Pulpal Pathology: * No Clinical Signs or Symptoms of Pulpal Pathology: The patient exhibits no clinical signs or symptoms indicative of pulpal pathology, such as pain, swelling, or sensitivity. * No Pulpal Pathology Visible on X-Ray: Radiographic evaluation shows no signs of pulpal pathology, such as radiolucency or periapical lesions. 3. Tooth Exfoliation: * Natural Tooth Exfoliation: The tooth exfoliates naturally, without the need for extraction.
次要结局
- Minor failure(Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.)
- Major failure(Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.)
研究者
P K Saraswathi Bai
Post Graduate Student
C K S Teja Institute Of Dental Sciences & Research