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临床试验/NCT05948228
NCT05948228尚未招募1 期

Principal Investigator,Resident at Cairo University

Cairo University0 个研究点目标入组 330 人开始时间: 2023年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
330
主要终点
incidence of white spot lesions using DIAGNOdent

研究概览

简要总结

white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.

详细描述

Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment.

The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients.

Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect.

Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.

研究设计

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

盲法说明

double

入排标准

年龄范围
15 Years 至 28 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients assigned for orthodontic treatment with fixed appliances
  • Sound teeth with fixed orthodontic appliances
  • Either maxillary or mandibular teeth or both

排除标准

  • Patients with poor oral hygiene
  • Allergic reaction to the materials used.
  • Lack of compliance.
  • xerostomia
  • Evidence of parafunctional habits.
  • Active carious lesions
  • Dental fluorosis
  • Hypocalcified teeth
  • Systemic diseases affecting teeth such as Amelogenesis imperfecta
  • Severe periodontal affection

研究组 & 干预措施

Application of bioactive gel on teeth in patients assigned for orthodontic treatment

Experimental

Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing

干预措施: giomer based bioactive gel (Drug)

Application of Fluoride on teeth in patients assigned for orthodontic treatment

Active Comparator

Application of fluoride gel will be done using a gel loaded tray held in the mouth for 4 minutes .After removal of tray ,patients must spit out the residual gel. The use of suction is a must to avoid the problem of over ingestion

干预措施: Fluoride gel (Drug)

结局指标

主要结局

incidence of white spot lesions using DIAGNOdent

时间窗: Baseline,change from baseline at 3 months,6 months,9 months and 12 months

the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent

次要结局

  • incidence of white spot lesions using ICDAS (international caries detection and assessment system)(Baseline,change from baseline at 3 months,6 months,9 months and 12 months)

研究者

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

Farah Khaled El Hindawy

Prevention of white spot lesions in patients undergoing orthodontic treatment using bioactive gel versus fluoride gel

Cairo University

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