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临床试验/NCT01165970
NCT01165970终止2 期

Vergleichende, Randomisierte, Kontrollierte Und Doppelblinde In-situ-Studie Zur Wirkung Von Speichelersatzmitteln Auf Schmelz Und Dentin

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2009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
状态
终止
入组人数
19
试验地点
2
主要终点
Mineral loss and lesion depth of specimens

研究概览

简要总结

Symptomatic hyposalivation is associated not only with Sjögren's syndrome or salivary gland hypofunction in elderly patients, but also with medications containing antimuscarinic drugs, chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson & Ava, 1994, Kielbassa et al., 2006).

Human saliva possesses important physiological functions in protecting and moistening the oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation causes oral dysfunction and promotes severe oral side effects (reduced antibacterial function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These have been identified as being responsible for the rapid destruction of the dentition (Willich et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms in patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen & Veerman, 2003, Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa, these products should also protect dental hard tissues. However, in vitro studies revealed that some marketed products have only a neutral or even a demineralising potential on enamel as well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al., 2001, Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have been added to saliva substitutes in order to enhance their remineralising property or minimize their demineralising potential (Tschoppe et al., 2009). Furthermore, as most patients suffering from hyposalivation are elderly people, recessions and subsequently exposed dentin surfaces are very common. Since dentin is not as acid resistant as enamel, an earlier and more severe demineralisation can be expected (Saunders & Meyerowitz, 2005).

Therefore, the current in situ study was performed to assess the effects of a demineralising and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not result in enhanced remineralisation when combined with a remineralising artificial saliva (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg, Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a difference.

详细描述

see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • stimulated salivary flow rate < 0.5 ml/min
  • partial denture upper or lower jaw
  • radiationtherapy in the head and neck area
  • patient age above 18 years
  • Signed informed consent (AMG §40 (1) 3b)

排除标准

  • stimulated salivary flow rate > 0.5 ml/min
  • missing partial denture upper or lower jaw
  • missing Radiationtherapy in the head and neck area
  • paraben allergy
  • not signed informed consent (AMG §40 (1) 3b)

研究组 & 干预措施

Glandosane

Active Comparator

After in situ exposition the enamel and dentin samples will demineralize with Glandosane.

干预措施: Glandosane (Drug)

Saliva natura

Experimental

After in situ exposition the enamel and dentin samples will remineralize with Saliva natura

干预措施: Saliva natura (Device)

结局指标

主要结局

Mineral loss and lesion depth of specimens

时间窗: 15 weeks

Evaluation of the mineral loss/lesion depth of the enamel and dentin specimens after in situ exposition evaluated with transversal microradiography. The Unit is the mineral oss as well as lesion depth.

次要结局

  • general and oral well being(15 weeks)

研究者

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

Peter Tschoppe

Dr.

Charite University, Berlin, Germany

研究点 (2)

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