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临床试验/NCT03774498
NCT03774498Unknown不适用

Effect of Different Over-the-counter Toothpastes on Enamel Remineralization: A Double Blinded Randomized Clinical Trial

Cairo University0 个研究点目标入组 52 人开始时间: 2019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
52
主要终点
Enamel remineralization

研究概览

简要总结

This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.

详细描述

Statement of problem:

Dental caries has been recognized as a dynamic process that results from an imbalance between the physiologic demineralization and remineralization of tooth structure. It has been well established that tooth undergoes cyclic demineralization of enamel crystals with periods of remineralization resulting from re-precipitation of calcium and phosphate ions from the saliva. If the process of demineralization dominates, caries result. However, if remineralization dominates along with removal of bacterial infection, enamel integrity gets restored. This basic knowledge of carious process brings us to an understanding that by controlling the amount, pattern and rhythm of demineralization and remineralization, carious lesions can either be controlled from progressing further or can be reversed. Several decades ago it was noted that clinically detectable white-spot lesions could be hardened; various scientific methods have been advocated for arrest and the reversal of incipient caries lesion by either decreasing the solubility of the mineral present or by increasing the mineral content of the previously demineralized tooth. Since remineralization occurring naturally in oral environment is often inadequate for maintaining strong decay free enamel and dentin, the process needs to be augmented by using some external means. It has been proposed that a simultaneous supply of calcium, phosphate and fluoride ions might serve as an invaluable tool to remineralize and strengthen the tooth structure by formation of calcium fluorapatite. Fluoride as a constituent of drinking water and in the form of various topically applied products especially over-the-counter toothpastes have a long successful history of use as a caries preventive agent.

NovaMin is claimed to release calcium and phosphate ions intraorally to help the self-repair process of enamel. A silica-rich surface layer forms through poly-condensation of hydrated silica groups on which precipitation of ions happens which crystallizes over time to form a hydroxyl-carbonate apatite. Although it is used extensively as a desensitizing agent reports also claim that the chemical reactions that promote apatite formation may enhance the remineralization. But there is limited clinical research to ascertain if there is any synergistic effect on combining anti-cariogenic activity of fluoride ions with these remineralization systems.

Direct benefit of the research to the human volunteer:

  • Have better remineralization for initial white spot carious lesions using recent Novamin technology.
  • Gain the other advantages for Novamin technology on the gingival health as well as dental health.
  • Patient will know the proper brushing technique as he would be given instructions about this during the study.
  • Patient will get to know the difference in efficiency of different over-the-counter toothpastes especially those assigned in the investigator's study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having at least two permanent tooth surfaces having white spot lesions (buccal/facial aspects of incisors, canines or pre-molars).
  • Subjects with orthodontic appliances.
  • Systemically healthy subjects of both genders, between the ages of 18 to 45 years, who were well versed with the use of toothbrush and dentifrice for oral hygiene maintenance, will be considered for the study.

排除标准

  • Presently on desensitizing treatment.
  • Subjects with bridge work that may interfere with evaluation.
  • Medical histories that may compromise study protocol.(including psychiatric and pharmaco-therapeutic problems)
  • Allergies.
  • Systemic conditions which are etiologic/predisposing to dentinal hypersensitivity (Enamel and dentine genetic abnormalities).
  • Eating disorders.
  • Pregnancy or breast feeding.
  • Any other pathology.
  • Known history of allergies to toothpaste contents.

研究组 & 干预措施

Sensodyne repair and protect

Active Comparator

NovaMin & fluoride toothpaste

干预措施: Sensodyne repair and protect (Drug)

结局指标

主要结局

Enamel remineralization

时间窗: 8 weeks

Decalcification index: (0):No white spot ,(1):Visible white spots ,no surface interruption (mild),(2):Visible white spot with roughened surface,not require restoration (moderate),(3):Visible with surface interruption (severe), (4):Cavitation. International Caries Detection and Assessment System:(0):Sound tooth surface: No evidence of caries after 5 sec air drying ,(1):First visual change in enamel: Opacity or white or brown discoloration visible after prolonged drying,(2):Distinct change in enamel visible when wet, must be visible when dry,(3):Localized enamel breakdown (no visual signs of dentin involvement) seen when wet and after prolonged drying,(4):Underlying dark shadow from dentine,(5):Distinct cavity with visible dentine,(6): Extensive (more than half the surface) cavity with visible dentine. Scoring is done by photographs at the beginning and at follow-up visits with the same setting each time.

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

Mohammed Farag Abd El-Khalek kelany

Principal investigator

Cairo University

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