Comparative Analysis of Hall Technique and Conventional Method for Stainless Steel Crown Placement in Primary Molars With Approximal Caries: A Randomized Controlled Trial at Primary Healthcare Corporation, Qatar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Restoration survival over 12 months
研究概览
简要总结
This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries.
详细描述
Background:
The most common chronic disease in children and adolescents (6-19 years old) is dental caries. The conventional approach to treating carious lesions involves cavity preparation with rotary instruments, followed by restoration using composite resin, amalgam, or stainless steel crowns (SSCs).
Retrospective studies have shown that SSCs have a higher success rate compared to amalgam or resin-based restorations when used for multi-surface caries in primary teeth. Accordingly, the American Academy of Paediatric Dentistry (AAPD) recommends the use of SSCs as the treatment of choice for carious lesions involving more than one surface in high-risk children.
Recently, the Hall Technique (HT) has been used to seal caries in primary molars. This contemporary technique was first introduced in the literature in 2006 by Dr Norna Hall, while working in a high caries-risk area in rural Scotland. The technique is based on straightforward biological principles: the most important layer for caries progression- the superficial plaque layer- is left intact and sealed along with the carious lesion. This leads to the development of a less cariogenic flora within the plaque biofilm, thereby arresting or slowing the caries progression in primary teeth.
The Hall Technique involves cementing an SSC over a carious primary tooth without the use of rotary instruments or local anaesthesia, thus reducing discomfort and improving the child's behaviour during treatment.
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
- Single (Care Provider)
盲法说明
Single-blind
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant inclusion criteria:
- •PHCC paediatric dental patients:
- •Whose parents or legal guardians accept and sign the consent form
- •Who assent to participation.
- •Who aged 3-9 years old.
- •Who exhibit generally cooperative behavior.
- •Who exhibit good general health conditions.
- •Who are presenting at least one occluso-proximal lesion in a primary molar.
- •Tooth/ carious lesion inclusion criteria:
- •1. From clinical and radiographic examination, caries limited to the occluso-proximal surfaces and extending to enamel or dentine, cavitated or non cavitated.
排除标准
- •Uncooperative children who do not understand the procedure or tolerate biting the crown into its position without local anesthesia.
- •Children with special health care needs (SHCN) will be excluded.
- •Children with nickel allergies and sensitivity.
- •Tooth/ caries lesion exclusion criteria:
- •Tooth with signs or symptoms of dental infection or irreversible pulpitis such as:
- •A history of spontaneous unprovoked pain, a sinus tract, soft tissue inflammation not resulting from gingivitis or periodontitis, excessive mobility not associated with trauma or exfoliation, furcation/ apical radiolucency, or radiographic evidence of internal/ external resorption (Camp JH 2011).
- •Crowns severely destructed with caries, which considered non-restorable (Innes, N.P 2009).
- •Teeth with single surface (occlusal) caries.
结局指标
主要结局
Restoration survival over 12 months
时间窗: At 1 month, 6 months, 9 months, and 12 months post-treatment
Success: * Satisfactory restoration/crown, no intervention required * No clinical or radiographic signs or symptoms of pulp pathology * Tooth exfoliated Minor Failures: * Secondary caries or new lesions detected clinically * Crown presents perforation * Restoration fracture or wear - intervention required * Loss of restoration - tooth that can be re-restored * Crown loss - tooth able to be re-treated * Reversible pulpitis, which could be treated without the need for extraction or pulpotomy Major Failures: * Irreversible pulpitis or dental fistula/abscess requiring pulpotomy or extraction * Loss of restoration/crown - tooth not capable of being re-restored * Periradicular and/or furcation radiolucency
Occlusal Vertical Dimension (OVD) resolution
时间窗: Assessments will be conducted at baseline (before treatment), immediately after crown placement, and at follow-up visits at 1, 6, 9, and 12 months post-treatment, with particular emphasis on the 1-month follow-up.
Will be assessed only in the HT group using a millimetre dental probe.
次要结局
- Tooth survival over 12 months(At 1 month, 6 months, 9 months, and 12 months post-treatment)
- Procedural Time(At the time of treatment visit)
- Participant's cooperation(At the time of treatment visit)
- Participant's pain perception(At the time of treatment visit)
- Parents' perceptions and opinions regarding treatment(At the time of treatment visit)
研究者
Hanan Mohamed
Pediatric Dentistry Specialist
Primary Health Care Corporation, Qatar