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临床试验/NCT06696105
NCT06696105进行中(未招募)4 期

Clinical and Laboratory Evaluation of Icon® Resin Infiltration and Vanish™ XT Varnish, on Color Changes of White Spot Lesions

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月20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
进行中(未招募)
入组人数
60
试验地点
1
主要终点
color measurement

研究概览

简要总结

The goal of this clinical trial is to assess the efficacy of "Icon® resin infiltration" and "VanishTM XT varnish" in restoring the appearance of white spot lesions WSLs in healthy children affected with anterior white spot lesions. The main questions it aims to answer are:

1- Are Icon resin infiltration (RI) and Vanish™ XT varnish comparable in restoring esthetics of white spot lesions? Researchers will compare Resin infiltration to vanish xt varnish to see if they are effective in masking white spot lesions

Participants will:

  • Have their white spot lesions treated in the dental clinic by the intervention methods
  • Visit the clinic after 1 month, 3 months and 6 months to assess the restorations objectively and subjectively

详细描述

Aim

  1. Clinically assess the efficacy of "Icon® resin infiltration" and "VanishTM XT varnish" in restoring the appearance of WSLs
  2. Assess patients/parents' satisfaction after "Icon® resin infiltration" and VanishTM XT varnish" application.
  3. Evaluate the changes in lesion size by using cross-polarization photography. Materials and Methods The study will be carried out in the "Department of Pediatric Dentistry, Faculty of Dentistry, King Abdulaziz University (KAU)", after approval from the Research Ethics Committee.

Study design A randomized, controlled trial comparing the application of "Icon® resin infiltration" and "VanishTM XT varnish" in parallel groups with a 1:1 allocation ratio. Also, an experimental in vitro study will be conducted.

Clinical trial (Color measurement) Participants, eligibility criteria, and settings A convenient sample of participants attending "King Abdulaziz University Dental Hospital" "KAUDH" will be recruited with WSLs affecting at least one of the labial surfaces of their permanent anterior teeth.

WSLs will be objectively screened Using "DIAGNOdent®" which will quantitively evaluate the loss of the associated fluorescence of WSLs (Q) as well as sound enamel surrounding lesion. The "DIAGNOdent®" device employs blue laser light to illuminate the teeth. The dentin of a tooth comprises fluorophores, which exhibit green fluorescence upon exposure to blue laser light. The presence of a WSL will appear as a dark region surrounded by a green reflective hue, which is observed as a reduction in fluorescence. WSL could easily be overlooked with the absence of "DIAGNOdent®". Only WSLs (Q) scores of 2-9 will be included.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Any systemic or local conditions not permitting intervention
  • Unwillingness to participate in the study
  • Teeth with periodontal diseases, dental caries, direct or indirect restorations, yellow-brownish opacities with post eruptive enamel breakdown.

研究组 & 干预措施

Resin infiltration arm

Experimental

resin infiltration will be applied on white spot lesion of anterior teeth

干预措施: Resin infiltration (Drug)

vanish xt varnish arm

Experimental

vanish xt will be applied on white spot lesion of anterior teeth

干预措施: Vanish XT varnish (resin modified glass ionomer restoration) (Drug)

结局指标

主要结局

color measurement

时间窗: 6 months

The variance in the value of colors that are observed between two cohorts undergoing therapy, using vita shade spectrophotometer over a six-month period.

次要结局

  • color stability(6 months)

研究者

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

Deem Abdullah Al-Blaihed

Principal Investigator

King Abdulaziz University

研究点 (1)

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