Comparative Study on the Clinical Outcomes of Restoring Dentine Caries Lesions in Primary Molars Using Silver Modified Versus Conventional Atraumatic Restorative Treatment (A Randomized Clinical Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- primary outcome : Success rate of restorations assessed by Modified ART Criteria
研究概览
简要总结
The goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with Early Childhood Caries (ECC). The main questions it aims to answer are:
- Which treatment method (ART or SMART) results in higher clinical success after six months?
- How do ART and SMART treatments affect the Oral Health-Related Quality of Life (OHRQoL) of the children? The researcher will compare teeth restored using ART with those treated using SMART (which includes the application of silver diamine fluoride before restoration) to see if one approach leads to better restoration outcomes and to assess how these restorations will impact the quality of life.
Participants will:
- Receive both types of treatments in different teeth (split-mouth design).
- Undergo clinical evaluation of the treated teeth at baseline and six months to assess success based on restoration retention, integrity, and absence of secondary caries.
- Have their parents complete a quality-of-life questionnaire (A-ECOHIS) at the start and at the six-month follow-up.
详细描述
Aim of the Study in details:
Primary Aim
This study aims to evaluate and compare the clinical outcomes of Silver-Modified Atraumatic Restorative Treatment (SMART) and conventional Atraumatic Restorative Treatment (ART) in the management of carious primary molars in preschool children. This comparison includes:
- Success rate: which include restoration integrity, marginal adaptation, absence of secondary caries, and tooth vitality.
- Retention rate: Determined by monitoring whether the restoration remains fully or partially retained over time
- Caries arrest: where arrested lesions present with hard, darkened surfaces and no progression in lesion size Secondary Aim
- To describe the change in oral health-related quality of life of preschool children before and after placement of ART and SMART restorations Randomization The sample size was specified by using the G* power test, assuming a statistical level of significance of 95% and power of 80% with normal distribution, and effect size calculated from means and standard deviation of 2 groups obtained from a previous similar study (Jiang et al.,2021). The original sample size was 64 molars and was increased up to 80 to avoid any drop out.
Eligible molars were randomly and equally assigned to either the SMART or ART group using a randomization software (Random.org).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The data analyst performing statistical evaluations was masked to group allocation during the initial analysis.
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Participants: Generally healthy children aged 3 to 7 years
- •Behavior Rating (Frankel's Scale):
- •Negative (Score 2) Positive (Score 3)
- •Dental Condition: At least two bilateral asymptomatic decayed primary molars
- •Caries Classification: based on International caries detection and assessment systemII I(CDAS II) Scores 4 & 5 (Occlusal or occluso-proximal carious dentin lesions)
排除标准
- •Children with systemic diseases/conditions (ASA Type I)
- •Behavior Rating (Frankel's Scale) Definitely positive(Score 1) Definitely negative (Score 4).
- •Teeth showing irreversible pulpitis or pulpal pathology (abscess, fistula, mobility)
- •Teeth with very deep cavities or score 6 based on ICDAS II
研究组 & 干预措施
ART- Atraumatic Restorative Treatment
Children received Atraumatic Restorative Treatment (ART), which involved selective caries removal using hand instruments and restoration with high-viscosity glass ionomer cement. Carious dentin was excavated from the axial walls with a spoon excavator, unsupported enamel was removed with a hatchet, and only soft demineralized dentin on the pulpal floor was removed until firm dentin was reached.
干预措施: ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment (Drug)
SMART_Silver-Modified Atraumatic Restorative Treatment
Children received Silver-Modified Atraumatic Restorative Treatment (SMART), which included the application of 38% silver diamine fluoride (SDF) followed by ART. Gingival tissues and lips were protected with petroleum jelly. One drop of SDF (Advantage Arrest™, Elevate Oral Care, USA) was placed into a disposable dish and applied to affected tooth surfaces using a bent micro-sponge for at least 60 seconds. Excess was blotted with a cotton pellet, and the area was air-dried under isolation for up to three minutes. ART was then completed using high-viscosity glass ionomer cement.
干预措施: ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment (Drug)
结局指标
主要结局
primary outcome : Success rate of restorations assessed by Modified ART Criteria
时间窗: 6 months post-treatment
The proportion of restorations that meet criteria for success based on Modified ART CRITERIA evaluation UNIT OF MEASURE: % OF restorations rated successful
次要结局
- Change in Oral Health-Related Quality of Life (OHRQoL) assessed by Early Childhood Oral Health Impact Scale (ECOHIS) filled by parents(Baseline and 6-month follow-up)
研究者
Sana Solh
Clinical Instructor
Beirut Arab University