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临床试验/NCT02913885
NCT02913885Unknown2 期

Comparative Study Using Biomimetic Remineralization Versus Fluoride Varnish In Management Of White Spot Lesion In Post Orthodontic Treated Patient: (Split Mouth Technique ) A Randomized Clinical Trial

Cairo University0 个研究点目标入组 64 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
64
主要终点
change in patient satisfaction

研究概览

简要总结

The aim of this study is to compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments

详细描述

Roles and responsibilities:

  1. Aalaa Mohamed Nabil Amin Abdullatif (A.N.) Operator, data enterer and corresponding author; Assistant lecturer, Conservative Dentistry Department, ModernTechnology University, Egypt.
  2. Mohamed Riad (M.R) Main supervisor, data monitoring, auditing Professor, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  3. Rasha Haridy (R.H.) Co-supervisor, data entry and auditing; Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  4. Ahmed Refaat Mohamed (A.R.) Outcome assessors and data collection; Lecturers, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  5. Heba fathy (H.F) Outcome assessors and data collection; Assistant lecturer,, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  6. Ahmed Mamdouh Ahmed (A.M.) Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  7. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  8. Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  9. Research Ethics Committee (CREC) Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants; Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1-Intervention: A.N. will treat the lesion with 2 % NaOCl for 20 sec, then rinsed and dried. A.N. will etch the lesion with 35 % Phosphoric acid for 20 sec to open up the pores to the subsurface lesion and sub¬sequently rinsed with water for 20 sec and air-dried. A.N. will apply (CURODONT™ REPAIR,Credentis, Switzerland) for two to three minutes. A.N. will advise the patients to rinse the quadrant containing the treated teeth using chlorhexidine mouthwash (Corsodyl, Herrenberg, Germany) until Day 4 and avoid teeth brushing. At D4, A.N. will ask the patients to use a soft tooth brush and tooth paste until Day 8. At this point they will be reverted to their normal oral hygiene procedures.

2-Comparator: A.N. will apply (2.26% F, Duraphat, WoelmPharma,Gesellschaft mit beschränkter Haftung, Germany). onto the tooth surfaces with White Spot Lesions using a brush, with the applicator dabbed repeatedly onto the tooth surface without contacting soft tissues. After a few minutes, a thin and clear layer is formed. A.N. will advise the patients not to brush their teeth or chew food for at least 4 hrs after treatment; during this time, soft food and liquid might be consumed.

3-Outcomes:

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
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • No systemic disease.
  • Has completed fixed orthodontic treatment, brackets debonded.
  • Has at least two teeth with white spot lesion.
  • Has received conventional periodontal therapy after orthodontic treatment.
  • Between the ages of 12 and 25 years of age

排除标准

  • presence of enamel hypoplasia or dental fluorosis.
  • presence of tetracycline pigmentation.
  • periodontal pocketing of 3mm or greater.
  • taking antibiotics.
  • presence of carious cavities.
  • allergy to fluoride gel / varnish being used in study.
  • Subjects who had evidence of reduced salivary flow or significant tooth wear

研究组 & 干预措施

Group 2

Active Comparator

curodont repair is a biomimetic regeneration scaffold for remineralization

干预措施: Curodont Repair (Drug)

Group 2

Active Comparator

curodont repair is a biomimetic regeneration scaffold for remineralization

干预措施: fluoride varnish (Drug)

Group 1

Experimental

fluoride varnish inhibit progression of white spot lesion

干预措施: Curodont Repair (Drug)

Group 1

Experimental

fluoride varnish inhibit progression of white spot lesion

干预措施: fluoride varnish (Drug)

结局指标

主要结局

change in patient satisfaction

时间窗: before, after 3 and 6 months

using visual analogue scale from 0-100 (0= not satisfied , 100= totally satisfied)

次要结局

  • change in color shade(before, after 3 and 6 months)

研究者

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

Aalaa Mohamed Nabil

assistant lecturer, conservative Dentistry Department MTI university

Cairo University

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