Remineralization Efficacy of Moringa Oleifera Varnish Vs MI Varnish in Initial Carious Lesions Over 6 Months Follow Up: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Remineralization efficacy
研究概览
简要总结
This randomized clinical trial aimed to test the remineralization effect of laboratory prepared Moringa Oleifera based varnish compared to MI varnish (CPP-ACP) on incipient carious lesions. The study could include any of the following participants: age: 25-35 years, males or females, presentation with at least one active WSLs on the study teeth at the start of the study, good oral hygiene, co-operative patients approving to participate in the trial, have sufficient cognitive ability to understand consent procedures. The main question it aims to answer is in patients with initial caries lesions will Moringa Oleifera varnish have same remineralization efficacy as MI Varnish after 6 months follow up? MI varnish will be used as a comparator as it has been shown in many studies to be superior to fluoride varnish with NaF alone in arresting early caries lesions. The active ingredient, CPP-ACP can slowly release, localize and stabilize amorphous calcium, phosphate, and fluoride on the enamel surface which aids in deep mineralization of white spot lesions.
详细描述
The aim of this randomized clinical trial is to evaluate the remineralization efficacy of Moringa Oleifera varnish in comparison to CPP-ACP Varnish on initial carious lesions over 6 months follow up period The null hypothesis is that there will be no difference in the remineralization effect between Moringa Oleifera varnish and CPP-ACP Varnish on incipient carious lesions after 6 months follow up.
- Study design: Randomized clinical trial.
- Double-blinded (participants and outcome assessors).
- Allocation ratio; 1:1
- Framework: Superiority frame.
PICOTS:
P (Population): patients (25-35 years) with active non-cavitated incipient carious lesions on the facial surface (smooth surface lesion).
I (Intervention): Moringa Oleifera-based varnish C (Comparator): CPP-ACP Varnish
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)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of participants:
- •Presentation with at least one active WSLs on the study teeth at the start of the study.
- •Good oral hygiene.
- •Co-operative patients approving to participate in the trial.
- •Have sufficient cognitive ability to understand consent procedures Inclusion criteria of teeth.
- •Active non-cavitated initial carious lesions (ICDAS 1&2)
- •DIAGNOdent score between (8-15)
- •Vital teeth with no signs or symptoms of irreversible pulpitis.
- •No signs of clinical mobility.
- •Teeth with healthy periodontium.
排除标准
- •of participants:
- •Participants with parafunctional habits or bruxism.
- •Participants with dry mouth.
- •Participants with systemic diseases or disabilities that may affect participation.
- •Heavy smoking.
- •Pregnancy.
- •Lack of compliance.
- •Severe or active periodontal disease.
- •Cognitive impairment
- •Exclusion criteria of teeth:
- •DIAGNOdent score less than 8 and more than 15
- •Untreated cavitated lesions or extensive restorations on the facial surfaces of the study teeth
- •Intrinsic or extremely heavy extrinsic staining
- •Periapical pathosis or signs of pulpal pathology.
- •Non-vital tooth.
- •Signs of pathological wear.
- •Endodontically treated tooth.
- •Severe periodontal affection or tooth indicated for extraction.
研究组 & 干预措施
MI varnish
MI Varnish application
The varnish will be applied on the clean surfaces according to manufacturer instructions as follows:
- The foil cover of the MI Varnish unit dosage bottle will be peeled-off and MI Varnish will be stirred with the disposable brush before application.
- The surfaces will be covered with a thin uniform layer using a disposable bond brush to avoid clumping.
- The area will be allowed to become wet to ensure the setting of the varnish.
干预措施: Varnish (Other)
Moringa Oleifera based varnish
Moring Oleifera Varnish application Using a disposable bond brush, the varnish will be painted on the diagnosed surfaces, then the patient will be instructed to avoid brushing or flossing and to avoid hard and sticky food or any products that may contain alcohol (oral rinses, beverages, etc.) for the next 4 hours after application.
干预措施: Moringa Oleifera (Other)
结局指标
主要结局
Remineralization efficacy
时间窗: baseline, 3 months and 6 months
The DIAGNOdent will be used to quantify objectively the white spot lesions. For every patient, measurements with the DIAGNOdent will be performed and calibrated on a sound enamel (incisal one third of the central incisor) before actual readings. The teeth will be scanned carefully with the tip held in contact with the tooth surface and tilted around the measuring site so that fluorescence could be collected from all directions. Maximum reading will be recorded Singh et al.,(2016). DIAGNOdent scores: Shalaan et al.,(2023) * Score 1: 0-4 (healthy tooth structure) * Score 2: 5-10 (outer half enamel caries) * Score 3: 11-20 (inner half enamel caries) * Score 4: 21+ (dentin caries).
次要结局
- Caries lesion activity assessment(baseline, 3 months and 6 months)
研究者
Hend Taha Hanafi Mahmoud
Phd candidate
Cairo University