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临床试验/NCT05872542
NCT05872542招募中4 期

Clinical Effectiveness of Silver Diamine Fluoride on Arresting Caries Lesions in Children

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Change from Baseline in Dental Caries Activity using Arrested or Active caries characteristics at Week 24

研究概览

简要总结

Purpose: To assess the clinical effectiveness of silver diamine fluoride (SDF) to control asymptomatic cavitated carious lesions compared to conventional glass ionomer restoration in preschool children.

详细描述

  1. Introduction The global spread of COVID-19 has led to drastic modifications affecting different fields including the field of Pediatric Dentistry. The last emergent guidelines of dental caries management under and following the current pandemic status, specifically recommended minimization of Aerosol Generating Procedures (AGP) and shifting to non- and minimally invasive biological approaches for dental caries management like the use of Silver Diamine Fluoride (SDF).

In addition, convincing young children to cooperate during conventional restorative dental procedures could be stressful and usually challenging, where the dentist might be compelled to use advanced behavior management techniques such as sedation or general anesthesia.

The application of SDF focused on arresting and preventing dental caries progression, particularly in children. A high success rate was reported following SDF treatment in arresting dental caries progression. SDF treatment is also considered of low-cost, easy application technique, does not require extensive caries removal, and thus omits the need for local anesthesia administration.

The SDF clinical effectiveness is obtained through a series of chemical reactions that promote carious lesion arrest. Silver ions possess a bactericidal effect via the inhibition of bacterial cell wall synthesis and DNA synthesis resulting in the disruption of plaque biofilm formation. Both silver and fluoride ions in SDF synergistically enhance remineralization of affected tooth structure and formation of fluorapatite, silver phosphate, and calcium fluoride compounds; hence termed "Silver-fluoride pullet" to arrest dental caries. The formed precipitate not only causes occlusion of the dentinal tubules but also reduces collagen degradation following caries affection. Furthermore, the sustained bactericidal effect of SDF arises from the ability of silver-affected bacteria to kill living bacteria of the same species as they come into contact which is known as the "Zombie phenomenon".

However, SDF treatment has the side effect of staining everted carious lesions permanently black as a result of the precipitation of silver protein and silver phosphate complexes which could represent a barrier to its application. However, most parents compromise esthetics when their children are subjected to an invasive approach to dental caries management particularly under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
  • Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS index: code 3-5) affecting primary molars.
  • Absence of former history of spontaneous pain from the offending tooth/teeth.
  • Teeth with normal vital pulp response when assessed using sensibility test and absence of any signs of irreversible pulpitis or necrotic pulp degeneration.
  • Absence of abnormal grade of tooth mobility, swelling, or tenderness on palpation or percussion.
  • Absence of any evidence of peri-radicular pathosis, or internal- or external resorption on radiographic examination.

排除标准

  • Patients with proven allergy to silver compounds or any component of dental materials to be applied.
  • Patients or guardians who refuse to participate in the study or had poor acceptance of SDF treatment.
  • Patients with ulcerative gingivitis or stomatitis.

研究组 & 干预措施

Silver Diamine Fluoride (SDF)

Experimental

SDF will be applied once to affected carious teeth surfaces at the end of the first visit. Under proper isolation, only gross debris will be removed and SDF will be applied directly to the carious lesion using micro brush according to the manufacturer's instructions.

干预措施: Silver Diamine Fluoride (SDF) (Drug)

Glass ionomer restoration (GI)

Active Comparator

GI will be applied to carious lesions following the manufacturer's instructions.

干预措施: Glass Ionomer Restoration (GI) (Other)

Sodium Fluoride varnish with silver nano-particles (NaF-AgNP)

Active Comparator

NaF-AgNP will be applied once to affected carious teeth surfaces at the end of the first visit. Under proper isolation, only gross debris will be removed and NaF-AgNP will be applied directly to the carious lesion using micro brush according to the manufacturer's instructions.

干预措施: Sodium fluoride varnish with nano-sliver particles (NaF-AgNP) (Other)

结局指标

主要结局

Change from Baseline in Dental Caries Activity using Arrested or Active caries characteristics at Week 24

时间窗: Baseline and Week 24

Changing of affected carious lesion texture and color; from soft, rough yellow or brown lesion(active caries), to hard smooth dark brown to black color(arrested caries).

Mean Change from Baseline in Dental Caries Susceptibility using the CariScreen Caries Susceptibility Testing meter at Week 24

时间窗: Baseline and Week 24

CariScreen meter is a validated tool that measures adenosine triphosphate-driven bioluminescence for quantification of plaque bacteria to determine if the participant is at low risk (from 0- to 1500 RLUs) or at risk (from1501- to 9999 RLUs) of developing dental caries.

Mean Change from Baseline in Dental Caries Lesions using ICDAS score at Week 24

时间窗: Baseline and Week 24

The International Caries Detection and Assessment System (ICDAS) is a validated instrument that measures the surface changes of carious lesions by relying on surface characteristics. The ICDAS detection codes for coronal caries range from 0 to 6 depending on the severity of the lesion; code 0: sound tooth surface, code 1:white brown opacity affecting pit or fissure, code 2:distinct changes detected in wet-enamel, code 3: localized enamel breakdown, code 4: underlying dark shadow from dentine, code 5: distinct cavity in dentine, code 6: distinct cavity (more than half surface) in dentine.

Mean Change from Baseline in Dental Caries Lesions using dmfs index at Week 24

时间窗: Baseline and Week 24

The dmfs index is a validated tool that is used to assess the extent of dental caries experience affecting deciduous dentition where "d" stands for decayed, "m" stands for missing tooth due to caries, and "f" stands for filled tooth due to caries.

次要结局

  • Mean Change from Baseline in oral health status using the Plaque index score at Week 24.(Baseline and Week 24)
  • Mean Change from Baseline in oral health status using the Gingival index score at Week 24.(Baseline and Week 24)
  • Mean Change from Baseline in saliva pH using pH meter at Week 24.(Baseline and Week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abla A Arafa, MD

Associate Professor

Misr International University

研究点 (1)

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