Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Remineralization potential
研究概览
简要总结
Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth.
详细描述
Study design This study will be conducted as a randomized controlled clinical trial. Study setting The study will be carried out in the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Tanta University.
Group assignment:
Fifty children will be randomly allocated using simple random table into two groups as follows:
- Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish.
- Group II (control group): Teeth will be treated with fluoride varnish.
Ethical consideration The purpose of the present study will be explained to both the parents and children and informed consents will be obtained as well as ascents from children .The researcher will be obligated to do dental treatment for every child according to his-her condition as compensation according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of active non-cavitated carious white spot lesions with DIAGNO/dent reading from 5 to 17 ,on labial surfaces of permanent anterior teeth and International Caries Detection And Assessment System II (ICDAS II) ranging between 1 and
- •The children' age range between 10 to14 years old.
- •Children had completed fixed orthodontic treatment within the past week.
- •Good oral hygiene with a plaque index score 0 or
- •No systemic diseases or medication affecting salivary flow.
排除标准
- •Children with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia.
- •Children had fluoride application less than 3 months before the study.
- •Presence of restoration and cavitation on the surface to be treated.
研究组 & 干预措施
curodont repair fluoride plus
Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish.
干预措施: self assembling peptide p11-4 with fluoride (Drug)
fluoride varnish
Group II (control group): Teeth will be treated with fluoride varnish.
干预措施: 5% sodium fluoride varnish (Drug)
结局指标
主要结局
Remineralization potential
时间窗: 1 month
T0:baseline assessment --\> T1:1 month(Application of Curodont repair flouride plus /fluoride varnish andAssessment of white spot lesion regression)--\> T2: 3 months Assessment of white spot lesion regression__\>T3: 6 months assessment of white spot lesion regression by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: 1. First visual change in enamel. 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry. by:Diagnodent
次要结局
- Remineralization potential(3 months)
研究者
Sara Ahmed Fathy Mohamed
principal investigator
Tanta University