CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT IN OCCLUSAL DENTAL CARIOUS LESIONS: RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate if Silver Diamine Fluoride (SDF) is a more conservative and effective treatment in preventing the progression of mild occlusal caries compared to fissure sealant in patients aged 20-45 years with incipient molar caries. The main question it aims to answer is:
Is SDF more effective in arresting caries progression than fissure sealant? Does SDF prevent the formation of new caries compared to fissure sealant? Researchers will compare SDF treatment to fissure sealant application to see if SDF results in better caries arrest and fewer new carious lesions.
Participants will:
Be randomly assigned to receive either SDF or fissure sealant. Have follow-up assessments at 1, 3, 6, and 12 months for caries progression, arrest, and new caries formation.
Undergo clinical evaluations using visual and tactile examinations to assess caries arrest and progression and using DIAGNOdent laser fluorescence system .
详细描述
This randomized clinical trial aims to assess the efficacy of Silver Diamine Fluoride (SDF) compared to fissure sealant in arresting mild occlusal caries. The study is focused on patients aged 20 to 45 years who present with incipient caries in the molar teeth, classified under ICDAS 1 and 2. The study will be conducted at the Cairo University Dental Hospital, a tertiary healthcare and referral center.
The null hypothesis is there is no difference in the clinical performance between the application of silver diamine fluoride and fissure sealant in occlusal dental carious lesions.
Participants will be randomly assigned to one of two groups:
SDF Group: Silver Diamine Fluoride (38%) will be applied to the affected tooth surface. The treatment will be carried out by isolating the tooth, drying it thoroughly, applying SDF using a microbrush, and allowing it to remain on the surface for up to 3 minutes. Afterward, any excess will be removed, and the patient will be advised to avoid eating for 30 minutes.
Fissure Sealant Group: Fissure sealant (resin-based) will be applied to the affected occlusal surface. This procedure involves etching the surface with phosphoric acid, applying the sealant, and then curing it using a light-curing device. The sealant will form a protective barrier to prevent further demineralization.
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
- None
盲法说明
Biostatistics: The study was divided into two groups, Group A and Group B. The materials used in each group were blinded to the statisticians conducting the analysis.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consulting in the outpatient clinic.
- •Patients with enamel caries in molars permanent teeth, according to ICDAS 1 and
- •Provide informed consent.
- •Co-operative patients approving to participate in the trial.
- •Patient age (20-45 years old).
排除标准
- •Tooth mobility.
- •Signs of pulpal infection.
- •Severe medical conditions that would not allow management in the clinic.
- •Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta.
- •Known allergies or sensitivities to dental materials, including SDF and fissure sealant.
- •Inability to return for recall visits.
- •Patients with bad oral hygiene
- •Refuse to participate in the study.
研究组 & 干预措施
VOCO Fissurit
Sealants are restorative dental materials applied to the pit-and-fissure surfaces of teeth. Upon application, the sealant material infiltrates the pits and fissures, subsequently polymerizing to form a hardened layer. This layer serves as a physical barrier, effectively preventing or restricting the penetration of bacteria and nutrients, thereby mitigating the risk of caries formation in these susceptible areas. Pit and fissure sealants: Evidence-based recommendations support the use of sealants for the prevention and management of pit and fissure caries. Sealants are effective and should be applied to the occlusal surfaces of first and second permanent molars. Additionally, non-operative cleaning of fissures with a toothbrush or bristle brush is recommended.
干预措施: VOCO Fissurit (Other)
Silver Diamine Fluoride (SDF)
Advantage Arrest Silver Diamine Fluoride 38%-SDF is an anti-microbial and remineralizing liquid clinically applied to control and arrest active dental caries and stop hypersensitivity. It is a safe, painless alternative to traditional cavity drilling procedures with the Power of Silver and Fluoride. Silver acts as an antimicrobial agent that simultaneously strengthens the dentin. Fluoride is the active ingredient that puts a stop to tooth decay by remineralising and helps prevent additional decay from appearing. It is also helpful to get relief from hypersensitivity.
The only common side effect is SDF causes black staining, but SDF/KI and NSF may reduce this staining effect. SDF can also stain surfaces that it comes into contact with when being applied, such as clothing or nearby tissues in the mouth. For best results, SDF should be reapplied every 3, 6, or 12 months, If the cavity still progresses.
干预措施: Silver Diamine Fluoride (SDF) (Other)
结局指标
主要结局
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria
时间窗: 1-3-6 and 12 month
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria. The fissure sealant and SDF will be evaluated at each recall visit for caries arrest through visual and tactile assessment, Arrested caries treated with silver diamine fluoride is clinically characterized by increased hardness and dark brown to black coloration . The clinical examination of fissure sealants involved evaluating the presence of visible cavitation. Although lesions can be seen through sealants. Active caries will be identified when a blunt probe, applied with light pressure, can easily penetrate the lesion surface. Conversely, inactive (arrested) caries will be observed if the lesion surface is firm, smooth, and free from plaque. The number and percentage of arrested carious lesions will be recorded and assessed.
次要结局
- evaluate carries arrest and new caries formation, measured by DIAGNOdent laser fluorescence system(1-3-6 and 12 month)
研究者
Amr Abir Atmaz Alsibaee
Principal Investigator
Cairo University