Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Size of WSL ( white spot lesion )
研究概览
简要总结
The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Double blinded ( participant and statistician )
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy cooperative children
- •Aging from 3-5 years old child
- •Both genders
- •Primary teeth with active WSLs on buccal or labial surfaces
- •Patient and parent acceptance to treatment and maintenance of good oral hygiene
排除标准
- •Restored teeth
- •White spot lesions due to fluorosis
- •Teeth with hypoplasia
- •Lesions that require an invasive treatment
- •Any pathology or concomitant medication affecting salivary flow or causing dry mouth
研究组 & 干预措施
Curodont Repair® ( monomeric self - assembling peptide P11-4 )
Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals.
干预措施: Monomeric self - assembling peptide P11-4 (Drug)
Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- )
Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp.
干预措施: Tricalcium phosphate fluoride varnish, 5% F- (Drug)
Voco-profluorid® fluoride varnish (5% sodium fluoride)
Fluoride varnish is the gold standard for treating WSLs.
干预措施: fluoride varnish (5% sodium fluoride) (Drug)
结局指标
主要结局
Size of WSL ( white spot lesion )
时间窗: through study completion, an average of 8 months
Size of WSL measured by scored dental probe
次要结局
- Regression of caries(through study completion, an average of 8 months)
- Inactivation of active carious lesions(through study completion, an average of 8 months)
- Mineral content of WSL(through study completion, an average of 8 months)
研究者
Yara Ahmed Ibrahim Abdellatif
Principal Investigator
Cairo University