Clinical and radiographical evaluation of the effectiveness of silver diamine fluoride on the success of composite resin and glass ionomer cement in class I restorations in deciduous molars: A randomized clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CLINICAL SUCCESS
研究概览
简要总结
Dental caries remains one of the most common dental diseases globally and is a leading cause of toothache and tooth loss. Defined by Fejerskov and Kidd as the localized destruction of dental hard tissues by acidic by-products from bacterial fermentation of dietary carbohydrates, it is particularly concerning in the form of Early Childhood Caries (ECC). ECC is a severe and rapidly progressing form of caries affecting the primary teeth of infants and toddlers, often beginning on anterior surfaces and potentially affecting molars. It starts as a white spot lesion and can lead to complete crown destruction and cavitation.
Early intervention is critical for maintaining the overall health and development of a child. Healthy primary teeth are vital for chewing, speech, aesthetics, and maintaining proper space for permanent teeth. Untimely loss of primary teeth can lead to complications in oral and facial development. Timely restorative care also minimizes the need for local anesthesia and supports better behavior management during dental visits.
Modern caries management emphasizes early detection, prevention, and minimally invasive treatments. Current practices favor conservative removal of caries followed by restoration using materials such as glass ionomer cement (GIC) or composite resins, with a move away from amalgam restorations. Non-invasive strategies include the use of fissure sealants, resin infiltration, topical silver diamine fluoride (SDF), and the Hall technique. Techniques like atraumatic restorative treatment (ART) and stepwise caries removal also focus on preserving pulp vitality by avoiding unnecessary exposure.
Silver diamine fluoride (38% SDF) has emerged as an effective agent in arresting carious lesions, especially in primary molars. Compared to no treatment or fluoride varnish, SDF is more effective at preventing caries progression and has shown comparable results to GIC restorations. Its effectiveness increases with repeated applications, offering a non-invasive, child-friendly approach to caries management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 4 to 9 years
- •Primary molars requiring new Class I (ICDAS 3 TO ICDAS 5)
- •Vital teeth with normal appearance and morphology
- •Teeth to be restored should be in occlusion
- •Normal periodontal status
- •Absence of radiographic pulpal involvement of dental caries.
- •Absence of any periapical pathology
- •Absence of furcal involvement
- •Good oral hygiene
- •A good likelihood of recall availability.
排除标准
- •Child below 4 years and above 9 years of age
- •Patients not signing consent.
- •Children lacking understanding ability
- •Children with physical & psychological disabilities
- •Children with underlying systemic diseases.
- •Unable to return for follow-ups;
- •Patients with partially erupted molars.
- •History of allergy to latex Children with silver allergy, oral ulcerations, or canker sores
- •Children with advanced gum disease
- •Physiological root resorption more than Apical 1/3rd of the root surface.
- •Signs of internal resorption/ external resorption.
- •Caries involving pulp 13.Periapical pathology
- •Signs of furcation involvement.
结局指标
主要结局
CLINICAL SUCCESS
时间窗: Baseline, 3 months, 6 months, 9 months
Color match, Marginal discoloration, Secondary caries, Marginal Adaptation, Anatomic form, Surface Texture, Gross fracture, Post-operative Sensitivity
时间窗: Baseline, 3 months, 6 months, 9 months
次要结局
- Marginal integrity(Baseline, 3 months, 6 months, 9 months)
