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临床试验/NCT04485299
NCT04485299Unknown2 期

Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 68 人开始时间: 2020年10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
68
主要终点
Dentin hypersensitivity

研究概览

简要总结

Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patient with free medical history.
  • Age range 18-60 years old.
  • Good oral hygiene
  • Patients suffering from pain due to dentin hypersensitivity.
  • Patient with sound first molar .

排除标准

  • Patients using desensitizing agents, receiving periodontal treatment or had received nonsurgical periodontal treatment in the last three months.
  • Patient wearing orthodontic appliance.
  • Patient with teeth having a painful condition involving the pulp and periapical region.
  • Patients who had allergy to materials will be used in the study.
  • Pregnancy.
  • Patient who does not consent to participation.
  • Patient who does not attend to the follow up.
  • A patient who has a carious first molar.

研究组 & 干预措施

bifluorid 10 varnish

Experimental

Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.

干预措施: Bifluorid 10 ,VOCO (Drug)

sodium fluoride varnish

Active Comparator

Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.

干预措施: Sodium Fluoride 5% Dental Varnish (Drug)

结局指标

主要结局

Dentin hypersensitivity

时间窗: 8 weeks

measurement of dentin hypersensitivity by VAS scale

次要结局

  • Dentinal tubule occlusion(8 weeks)

研究者

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

Zaid Yousef Fakhry Al khateeb

Master's degree student - faculty of dentistry

Cairo University

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