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临床试验/NCT04390256
NCT04390256已完成不适用

Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Remineralization of enamel

研究概览

简要总结

This study will be conducted to evaluate:

  1. The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test.
  2. The clinical efficacy of all agents in patients with early carious lesions.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Criteria related to patient:
  • Age's eligible for trial was 18- 30 years.
  • Patient able to read and sign the informed consent form.
  • Cooperative patient who are willing to participate and able to continue the schedule time of wok keep good oral hygiene throughout the study.
  • Healthy volunteers.
  • Patient with moderate and high caries index.
  • Criteria related to tooth:
  • Patient with at least 2 white lesions (WSL) detected clinically on the buccal surface of permanent anterior teeth, one on each side. WSL selected either due to caries or orthodontic treatment (just following deboning).
  • Teeth with score1, 2, 3 according to ICDAS II.
  • Absence of preoperative pain, no mobility & tenderness on percussion.
  • Radiographically, the pre-operative inclusion criteria were absence of internal or external resorption, no periapical radiolucencies and no widening of periodontal ligament space..

排除标准

  • Criteria related to patient:
  • Patient with Rampant uncontrolled caries.
  • Patient with compromised medical history.
  • Pregnant or breast feeding females.
  • Heavy smoker.
  • Patient who currently received extensive fluoride regiments for treatment of WSL.
  • Patients who planned to move within 3 months of enrollment.
  • Patient with evidence of xerostomia.
  • Criteria related to tooth:
  • Teeth with score 4, 5 according to ICDAS II.
  • Teeth with periapical pathology, internal or external resorption or exhibiting any symptoms of pulp pathology.
  • Teeth with questionable vitality or have root canal therapy.
  • Teeth have been pulp capped.
  • Teeth with periodontal pocket and bleeding on probing.
  • Cracked teeth.

结局指标

主要结局

Remineralization of enamel

时间窗: 3 months

Remineralization of enamel using Vista scan

次要结局

未报告次要终点

研究者

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

Marwa Mohamed

Ass. lecturer

Al-Azhar University

研究点 (1)

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