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临床试验/NCT05127889
NCT05127889Unknown不适用

Comparative Evaluation of the Remineralizing Ability of Self-Assembling Peptide P11-4, 2% Arginine Enriched Sodium Fluoride and Functionalized Tri Calcium Phosphate Fluoride Varnishes in Treatment of White Spot Lesions (Randomized Clinical Trial and In Vitro Study)

Ain Shams University0 个研究点目标入组 39 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
39
主要终点
dimensional and color assessment

研究概览

简要总结

The aim of the current study is to compare the remineralizing ability of Self-assembling peptide P11-4, 2% Arginine Enriched Sodium Fluoride and Functionalized Tri Calcium Phosphate Fluoride varnishes in treatment of white spot lesions both in-vivo and in-vitro .

A) Primary Objective

Assessment of:

  • Dimensions of the WSLs through digital photography.
  • The color of WSLs through spectrophotometer. B) Secondary Objectives

Assessment of:

• Degree of remineralization using Polarized Light Microscope.

详细描述

White spot lesions (WSLs), defined as "white opacity," occur as a result of subsurface enamel demineralization that is located on smooth surfaces of teeth. The reason of the white appearance is the changes in light-scattering optical properties of the decalcified enamel. The aim of the current study is to compare the remineralizing ability of Self-assembling peptide P11-4, 2% Arginine Enriched Sodium Fluoride and Functionalized Tri Calcium Phosphate Fluoride varnishes

A) Primary Objective

Assessment of:

  • Dimensions of the WSLs through digital photography.
  • The color of WSLs through spectrophotometer. B) Secondary Objectives

Assessment of:

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
Single (Participant)

盲法说明

double

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Self-assembling peptide P11-4 varnish (study group)

Experimental
  • Test lesions will be wiped with NaOCl to remove pellicle,
  • Etched for 20 s with 35% H3PO4 Etching Gel to remove mineral deposits on the tooth surface and rinsed with water in accordance with the manufacturer's instructions.
  • The lesions will be dried and isolated with cotton rolls.
  • The varnish will be applied and left undisturbed for 5minutes (till disappearance) to allow diffusion of self-assembly.

干预措施: curodont (Drug)

Arginine-enriched Sodium Fluoride varnish (study group)

Experimental
  • The Arginine powder will be suspended at 2%.
  • A 10 mL of 5% sodium fluoride varnish tube dispensed in a sterile container.
  • 200 mg of Arginine will be vigorously mixed with the varnish matrix for 60 sec using a sterile microbrush.
  • After dryness of the white spot lesion, the prepared varnish will be applied evenly using the micro brush.
  • After application the patient will be instructed to avoid rinsing, eating soft diet and avoid hot drinks for 2 hrs.

干预措施: curodont (Drug)

Tri Calcium Phosphate Fluoride varnish (positive control group)

Active Comparator
  • To limit undesirable oral ingestion, the appropriate dose for the patient will be determined with the help of the dosing guide.
  • The varnish will be mixed with the brush to avoid separation of the material during storage
  • However, to guarantee the best results suction will be used during application of the varnish.
  • A thin uniform layer of the varnish will be applied on the lesion surface by using the supplied brush
  • The applicator brush won't be moved through accumulated saliva to prevent premature setting on the bristles.
  • After application the patient will be instructed to close his mouth, avoid rinsing, eating soft diet and avoid hot drinks for 4 hrs.

All patients will be encouraged to maintain good oral hygiene through regular brushing.

干预措施: curodont (Drug)

结局指标

主要结局

dimensional and color assessment

时间窗: 1. Baseline 2. 3-month evaluation 3. 6-month evaluation 4. 9-month evaluation

Photographic assessment and color change reading outcomes will be assessed by two other blinded calibrated examiners

次要结局

  • Evaluation of the remineralizing ability and degree of remineralization of each agent(1 month)

研究者

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

bardis Sslah

assistant lecturer

Ain Shams University

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