Biomimetic Remineralization Using Self-Assembling Peptide P11-4 in the Prevention and Treatment of Early Carious Lesions in Primary Anterior Teeth: An In-Vivo and In-Vitro Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Remineralization of white spot lesions
研究概览
简要总结
This study is a randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from white spot lesions (ICDAS system II scores 1-2).
Forty four teeth will be divided into two groups where Group 1 (n=22 teeth) will receive Self-Assembling Peptide P11-4.
Group 2 (n=22 teeth) will receive Topical Fluoride Varnish Application.
Assessment will be done at baseline using the International Caries Detection and Assessment System II (ICDAS II) scoring system and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then after 3 months, 6 months and 1 year. The assessment of the baseline and follow up data will be performed by the main investigator.
详细描述
Patients aged 3-5 years with 44 teeth affected by white spot lesions (WSL) on their primary anterior teeth (ICDAS II scores 1-2) will be selected by simple random sample.
A minimum of 1 tooth and a maximum of 12 teeth affected by WSL in each patient can be included.
Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits.Subjects not on medication affecting their salivary flow and medically free (ASA class I).
- All participating patients' parents will sign an informed consent.
- Patients will receive oral information on oral health education on how to maintain a proper oral hygiene and proper diet consumption.
- They will be given manual tooth brushes and non-fluoridated tooth pastes to use during the study. The tooth brushes will be replaced every 3 months and the tooth pastes will be replaced whenever they are empty.
- Every patient will receive prophylaxis (polishing) using non-fluoridated prophylaxis paste prior to the commencement of treatment to avoid possible confounding factors.
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 blinded trial where patients won't know to which group they are assigned and where the outcome assessor will be blinded.
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
- •Healthy patients ASA Class I.
- •≥1 Primary Anterior Teeth with early carious lesions of ICDAS scores 1-
- •Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits.
- •Patients aged between 3-5 years.
- •Subjects with a minimum of 1 and a maximum of 12 primary anterior teeth with early carious lesions of ICDAS II scores 1-2.
排除标准
- •Primary anterior teeth in which carious lesions are scored with ICDAS ≥
- •Subjects on medication that affects the salivary flow rate.
结局指标
主要结局
Remineralization of white spot lesions
时间窗: One year
Remineralizing efficacy of self-assembling peptide P11-4 versus fluoride varnish using light induced fluorescence (Soprolife Camera). Patients' white spot lesions will be examined using Soprolife camera to identify the demineralized areas. At 3 months, 6 months, and 1 year after treatment their lesions will be re-assessed and compared with baseline data.
次要结局
- Caries progression or regression by ICDAS II system(One year)
- - Patient satisfaction/dissatisfaction(1 day)
研究者
Nour Wahba
Assistant Lecturer
Ain Shams University