Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of Molar Incisor Hypomineralization. In Vitro Study and In Situ Randomized Double-Blind Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- MIH TNI
研究概览
简要总结
In child patients with molar incisor hypo mineralization, Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index, decrease plaque accumulation, more gingival health and less bleeding on probing differentiated from placebo mouthwash?
详细描述
Molar incisor hypomineralization (MIH) refers to specific developmental qualitative defect of the enamel that typically affect 1 to all 4 of the permanent molars and can also involve the permanent incisors.
MIH is clinically characterized by morphological enamel defects that can be seen on the occlusal surface of permanent molars and the incisal one-third (or more) of the incisors result from hypomineralization. These defects more or less well-defined opacities that vary in size and can be discoloured from white to yellow brownish. The hypomineralized enamel is friable and has inferior mechanical properties as well as reduced modulus of elasticity when compared to sound enamel.
As a consequence, hypomineralized enamel leads to post-eruptive breakdown and hypersensitivity, and it is prone to development of carious lesions and pain. Due to pain, fragile enamel and increased treatment need at an early point of time in life, MIH treatment represents a clinical challenge. The well-defined opacities are focal subsurface decalcifications in enamel are commonly associated with extended plaque retention. Periodontal disease in children is mainly limited to gingival inflammation and is observed as gingival oedema, colour and contour changes, bleeding on probe or spontaneous bleeding.
Recent study showed that plaque accumulation and gingival inflammation were higher in patients with MIH compared with healthy children, and that oral hygiene and gingival health worsened as the severity of MIH increased.
Vitamin D, plays a pivotal role in many biological functions such as in innate immunity effect, the regulation of calcium (Ca+) and phosphate metabolism and their deposition in mineralized tissues. Since the presence of Vitamin D3 receptors on ameloblast and odontoblast cells, its function in tooth development and remineralization, changes in the biochemical composition of saliva and immunological modulation of dental infection has been suggested.
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)
盲法说明
Double-Blind Placebo
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •More than 6 years' child with all permanent incisors and first molar teeth are fully erupted with all surfaces visible.
- •At least one affected first permanent molar were considered to have MIH (Lygidakis et al. 2010; Kühnisch et al. 2014).
- •No chronic systemic disease
- •No acute infection
- •cooperative Child
排除标准
- •Drugs (chlorhexidine-based gels and mouthwashes)
- •Hypomineralization with a diameter less than 1 mm.
- •Hypoplastic defects, fluorosis (diffuse hypomineralization), amelogenesis imperfecta, and dentinogenesis imperfecta.
- •Defects on approximal surfaces and diffuse opacities.
- •Fixed orthodontic treatment
研究组 & 干预措施
Vitamin D mouthwash
a
干预措施: Vitamin D3 mouth wash (Drug)
Placebo mouth wash
干预措施: Vitamin D3 mouth wash (Drug)
结局指标
主要结局
MIH TNI
时间窗: 3 months
Gingival Index
时间窗: 3 months
Plaque Index
时间窗: 3 months
次要结局
- Bleeding on Probing(3 months)
研究者
Parryhan Mohamed Abdelsamie
Lecturer of periodontology
MTI University