An 18-Month Split-Mouth Randomized Clinical Trial Comparing the Hall Technique, Silver Diamine Fluoride, and Compomer Restorations for the Management of Caries in Primary Molars in Children Aged 4-8 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical success rate at 18 months
研究概览
简要总结
The goal of this clinical trial is to compare the 18-month clinical success rates of three caries management approaches in primary molars of 60 healthy children aged 4-8 years attending the Department of Pediatric Dentistry at Erciyes University, using a randomized split-mouth design involving 180 treated teeth. The three approaches include the Hall Technique, Silver Diamine Fluoride, and the conventional "drill-and-fill" restorative approach using compomer material. The study will also evaluate pain perception during treatment, child behavior, and treatment acceptability from the perspectives of patients, parents, and dentists. The main questions it aims to answer are:
- Do minimally invasive approaches (Hall Technique and Silver Diamine Fluoride) achieve comparable or superior 18-month clinical success rates compared to the conventional drill-and-fill restorative treatment?
- Do minimally invasive approaches result in lower pain perception, improved child behavior, and greater treatment acceptability compared to the conventional drill-and-fill approach?
Researchers will compare the three treatment approaches applied to different teeth within the same child to see if minimally invasive methods provide similar or improved clinical outcomes and better patient-centered outcomes over 18 months compared to the conventional approach.
Participants will:
- Contribute three eligible primary molars per child (180 teeth in total).
- Have each tooth randomly assigned to one of the three treatment approaches following a split-mouth design.
- Receive all three interventions within the same participant, with each treatment applied to a different tooth.
- Attend scheduled follow-up visits at 1 month after completion of all interventions, and at 6, 12, and 18 months (final follow-up) for clinical and radiographic evaluation of each treated tooth.
- Provide assessments of pain perception and treatment experience, with additional evaluations completed by parents and treating dentists.
详细描述
This randomized split-mouth clinical trial was designed to evaluate and compare the clinical performance and patient-centered outcomes of three different caries management approaches in primary molars of children.
Dental caries remains one of the most prevalent chronic diseases in childhood. Minimally invasive strategies such as the Hall Technique (HT) and Silver Diamine Fluoride (SDF) have gained increasing attention as alternatives to conventional restorative treatment, particularly in young or anxious pediatric patients. However, comparative clinical data evaluating long-term outcomes and patient-centered measures between these approaches and conventional restorative treatment remain limited.
A total of 60 healthy children aged 4-8 years requiring restorative treatment for at least three primary molars were included. Using a split-mouth design, each child contributed three eligible primary molars (total: 180 teeth). Within each participant, teeth were randomly allocated to receive one of the following interventions:
Hall Technique (placement of a preformed metal crown without caries removal or tooth preparation)
Silver Diamine Fluoride application
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
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 8 years.
- •Systemically healthy children without any medical or syndromic conditions.
- •Frankl Behavior Rating Scale score of 3 (positive) or 4 (definitely positive).
- •Presence of at least three unrestored, asymptomatic primary molars with active occluso-proximal dentine caries lesions (ICDAS codes 3, 4, or 5).
- •Written informed consent obtained from parents or legal guardians, with willingness to attend follow-up visits.
排除标准
- •Refusal to provide informed consent or unwillingness to participate.
- •Presence of systemic disease or chronic medical conditions requiring special care or antibiotic prophylaxis.
- •Teeth presenting mobility, symptoms, abscess, or tenderness to percussion.
- •Radiographic evidence of pulpal pathology.
- •Non-restorable teeth.
- •Children with severe lack of cooperation (Frankl score 1 or 2).
- •Refusal of treatment for aesthetic reasons by the parent or child.
研究组 & 干预措施
Hall Technique
Teeth randomly allocated to this arm were treated using the Hall Technique for the management of carious lesions in primary molars. The intervention consisted of cementation of a preformed stainless-steel crown (3M ESPE, USA) using glass ionomer luting cement, without caries removal, tooth preparation, or local anesthesia. In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. Clinical evaluations were performed at 1, 6, 12, and 18 months after crown placement.
干预措施: Hall Technique (Procedure)
Silver Diamine Fluoride
Teeth randomly allocated to this arm were treated with 38% silver diamine fluoride for the management of carious lesions in primary molars. Unsupported enamel was removed and the cavity surface was cleaned using a rotary bristle brush prior to application. A 38% silver diamine fluoride solution with potassium iodide (Riva Star Aqua, SDI, Australia) was applied, followed by 22,600 ppm fluoride varnish (Duraphat, GABA, Germany). In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. SDF applications were repeated at 6 and 12 months. Clinical evaluations were performed at 1, 6, 12, and 18 months.
干预措施: Silver diamine Fluoride 38% (Drug)
Compomer Restoration
Teeth randomly allocated to this arm were treated with conventional caries removal and restoration using compomer material for the management of carious lesions in primary molars. Complete caries removal was performed under local anesthesia when clinically indicated, followed by restoration with a compomer material (Dyract, Dentsply, Germany) according to the manufacturer's instructions. In this split-mouth randomized design, eligible teeth within the same child were allocated to different treatment arms. Clinical evaluations were performed at 1, 6, 12, and 18 months.
干预措施: Compomer Restoration (Procedure)
结局指标
主要结局
Clinical success rate at 18 months
时间窗: 18 months
Proportion of treated teeth without clinical or radiographic signs of failure, defined as absence of pain, abscess, fistula, pathological mobility, restoration or crown loss, or caries progression requiring further intervention. Outcomes are assessed through clinical and radiographic examination.
次要结局
- Pain perception during treatment(Periprocedural (Day 1))
- Child behavior during treatment(Periprocedural (Day 1))
- Child treatment acceptability(Periprocedural (Day 1))
- Parental treatment acceptability(Periprocedural (Day 1))
研究者
Maria Paula Rueda Manjarres
Doctor in Dentistry, Department of Pediatric Dentistry, Faculty of Dentistry, Erciyes University
TC Erciyes University