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临床试验/NCT03217084
NCT03217084Unknown4 期

Esthetic Effect of Casein Phosphopeptide-Amorphous Calcium Phosphate Varnish Versus Tricalcium Phosphate Varnish on Postorthodontic White Spot Lesions: A Randomized Pilot Study

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年12月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
20
试验地点
1
主要终点
Esthetic effect

研究概览

简要总结

Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH) 2), which is subjected to consecutive cycles of demineralization and remineralization. This is an interrupted process, with periods of remineralization and demineralization occurring, depending on the state of the oral environment in terms of the prolonged accumulation and retention of bacterial plaque on the enamel surface (Aoba, 2004).

Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant problem during and after orthodontic treatment with prevalence 71.1% and various preventive measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et al., 2011).

详细描述

In orthodontic patients, demineralization usually takes place in the form of white or brown spots on the enamel around the brackets and can lead to cavitation (Al Maaitah et al., 2011). White spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse.

Natural remineralization through saliva involving a mineral gain in the surface layer of white spot lesions has little improvement on the esthetic and structural properties of the deeper lesions (Karlinsey et al., 2009 and Cochrane et al., 2010). Management of white spot lesion should involve methods of both preventing demineralization and encourage the remineralization of existing lesions. In both of these processes, the efficacy of fluoride is well established. Fluoride increases the initial rate of remineralization of early enamel lesions. Consequently, it slows down the caries process and arresting the lesion. Fluoride varnish provides a protective coat over the tooth which adheres longer to the tooth surface (Demito et al., 2004 and Ten Cate et al., 2008).

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
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age ranging 11-16 years.
  • Good general health.
  • Exhibiting at least 2 white spot lesion in buccal surface of their teeth.

排除标准

  • Chronic use of medication causing dry mouth.
  • Oral ulcer, ulcerous gingivitis, acute bronchial asthma.
  • History of allergic reaction to fluoride or other ingredients in varnish.
  • Refusal of the patient to participate in the trial.
  • Any previous treatment done for white spot lesion.

研究组 & 干预措施

MI varnish GC

Active Comparator

MI Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDEN Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish . Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue.

干预措施: MI varnish GC (Drug)

White Varnish 3M

Active Comparator

White Varnish is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. White Varnish an innovative tri-calcium phosphate.

Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish . Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue.

干预措施: White varnish 3M (Drug)

结局指标

主要结局

Esthetic effect

时间窗: 6 months

Asking patient (yes or No)

次要结局

  • Clinical assessment(6 months)

研究者

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

Abdelrahman Yousef ALduqi

Master degree student

Cairo University

研究点 (1)

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