Clinical and Radiographic Evaluation of SMART Hall Versus Conventional Hall Technique In Children With Carious Primary Molars: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
Brief Summary
Dental caries is one of the most common chronic diseases affecting children, particularly in primary molars, and may lead to pain, impaired function, reduced quality of life, and an increased risk of caries in permanent teeth. Managing caries in young children can be challenging because of behavioral and developmental factors, highlighting the need for minimally invasive, child-friendly treatment approaches.
The Hall Technique is an effective minimally invasive approach that uses stainless steel crowns to seal carious primary molars without caries removal, tooth preparation, or local anesthesia. It has demonstrated high clinical success and good patient acceptance. However, concerns remain regarding the activity of residual bacteria within deeper carious lesions.
The Silver-Modified Atraumatic Restorative Technique (SMART) incorporates silver diamine fluoride (SDF), which has antibacterial and remineralizing properties, before restoration and sealing. This may provide additional caries-arresting and antibacterial benefits compared with the conventional Hall Technique.
Although both techniques have shown promising clinical outcomes, there is limited evidence directly comparing the SMART Hall technique with the conventional Hall Technique, particularly regarding long-term clinical and radiographic outcomes. Therefore, the proposed study aims to evaluate whether adding SDF to the Hall Technique improves treatment success in carious primary molars. The findings may help identify an effective, minimally invasive, and child-friendly approach for managing dental caries in pediatric patients.
详细描述
Dental caries continues to have a major effect on children's oral health and it is one of the most common chronic disorders impacting children globally. According to recent epidemiological research, carious lesions in primary molars are quite common in young populations, incidence rates among preschoolers and early school-aged children are estimated to be between 40 and 90%.
Consequences of this high incidence include pain, illness, impaired chewing function, a decreased quality of life, and an increased risk of caries in permanent teeth. Managing carious primary molars is further complicated by the behavioral and developmental challenges that pediatric patients often experience. This requires the use of kid-friendly, efficient, and minimally intrusive treatment techniques with less chair time and higher caries arrest.
The most popular restorative option for fixing and preserving the remaining structure of severely decayed or damaged teeth is stainless steel crowns. In 1947, they were first introduced to pediatric dentistry, first described by Engel, and then made popular by Humphrey in 1950.
For severely decayed primary teeth, stainless steel crowns (SSCs) are now a necessary restorative option. These crowns have prefabricated anatomy and come in a variety of sizes; to properly fit each tooth, they must be trimmed or contoured. This initial adjustment usually does not result in pain or discomfort, though it may cause variations in occlusal contact points.
Rationale of the Study:
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient-related inclusion criteria:
- •Children aged 4 to 8 years old.
- •One surface carious lesion.
- •No signs and symptoms. (e.g., no tooth pain)
- •Presence of one or more primary molar(s) with deep carious dentine.
- •Tooth-related eligibility criteria:
- •Presence of active cavitated carious lesions that can be removed by an excavator are accessible with hand instruments.
- •Vital pulp with symptom-free or reversible pulpitis.
- •No spontaneous/prolonged pain or percussion pain.
- •No abnormal mobility or signs of infection (swelling, fistula, abscess).
- •Sufficient tooth structure for stainless steel crown retention.
- •Deep caries lesions radiographically extend through at least the inner half of the dentine.
- •Presence of a clear band of normal-appearing dentine between the carious lesion and the pulp in a bitewing radiograph.
- •More than 2/3 of the roots remaining.
- •No internal/external resorption or periapical/furcation pathology.
排除标准
- •1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders).
- •2. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants.
- •3. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.
- •4. Patients allergic/sensitive to nickel since PMCs contain nickel.
- •Cases with significant space loss or reduced mesio-distal width due to interproximal caries (making crown fitting difficult).
- •6. Unaffected dentine between lesion and pulp cannot be confirmed clinically/radiographically.
- •7. Presence of extensive dental caries or additional oral pathology requiring urgent or specified dental care beyond scope of study.
研究组 & 干预措施
SMART Hall Technique, SDF before Conventional Hall Technique.
SDF is applied before the Conventional Hall technique to arrest the bacterial action.
干预措施: SDF with stainless steel crown (Other)
Conventional Hall Technique
Hall technique will be applied using glass ionomer cement under the stainless steel crown without SDF.
干预措施: Conventional Hall Technique (Other)
结局指标
主要结局
Clinical evaluation
时间窗: 12 months
1. Presence of pain on percussion: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO) 2. Presence of swelling: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO) 3. Presence of fistula: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO) 4. Presence of mobility: Measuring device: Clinical examination by the back of the mirror and asking the patient if there is pain on percussion. Measuring unit: (If present: Yes , if absent: NO)
次要结局
- Radiographic Evaluation(12 months)
研究者
Rana Amr
Pediatric Dentist.
Cairo University