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临床试验/CTRI/2020/02/023667
CTRI/2020/02/023667尚未招募Unknown

Effect of commercially available anti-streptococcus IgY containing tablet onStreptococcus mutans count in caries active children: In vivo study

Inzpera Healthsciences Ltd A Subsidiary of Tata Industries Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月3日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Percent reduction in S Mutants count after administration of NoDecay chew able tablet.

研究概览

简要总结

Despite exhaustive research and advances in oral health sciences, dental caries still remains as one of the most prevalent afflictions in modern man, affecting humans of all ages, especially children where caries disease is on the rise.  Great strides have been made in understanding the pathogenesis of dental caries. Infection as a key component in the etiology of caries was uncovered around 110 years ago by Miller who made the link among microorganisms, dietary carbohydrates, and dental caries.

Although molecular, biological and cultural techniques have also implicated role of other bacteria in the process and extension of dental caries in, S mutanscontinues to be Enemy of teeth #1, especially for early childhood dental disease.  The infectious nature of dental caries imprecates the hypothesis that some form of host immunity can regulate caries activity.

Several attempts to develop successful vaccine against dental caries have been undertaken in the past three decades. However immunogenic antigens of Streptococcus mutans share epitopes with human IgG and cross react with human rheumatoid anti-IgG antibodies.  An immunological intervention for prevention of caries other than the vaccination is passive immunization. This has a considerable advantage as it completely avoids any risk that may arise from active immunization.

 Strategies include the development of antibodies to Mutans streptococcal antigens in cow’s milk and hen’s eggs and the genetic engineering of human-like S-IgA antibodies in plants. Successful passive immunization has been done in rats using orally administered hen yolk antibodies against Streptococcus mutans1 and topical anti- streptococcus mutans IgY gel.

 Studies on human volunteers have demonstrated reduction in Streptococcus mutans count when mouth-rinse containing IgY against S. mutans whole cell antigen and cell associated glucosyl transferase enzyme was used. Tooth paste incorporated with anti S. mutansIgY was found to be effective in reducing caries in deciduous teeth in human volunteers .

Recently chewable tablets containing IgY against Streptococcus mutans have been launched by the trade name of NoDecayâ„¢ (Inzpera Healthsciences Limited). The tablet contains Egg Yolk protein powder (Delipidated), Mannitol, Maltitol, Xylitol, cross carmellose sodium, peppermint, orange flavour, microcrystalline cellulose, steviol glycoside, magnesium stearate, talc and colour. The tablets have been recommended for children above 5 years of age and to be used twice daily.

The present study is undertaken to evaluate the efficacy of NoDecayâ„¢ tablet on percentage reduction in Streptococcus mutans count in caries active children.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
5.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Patients having 5 active carious teeth.
  • Patients not requiring antibiotics.
  • No systemic illness and pathology.

排除标准

  • Use of systemic Antibiotics in last 30 days.
  • Use of mouthwash in last 30 days.
  • Allergic to egg.

结局指标

主要结局

Percent reduction in S Mutants count after administration of NoDecay chew able tablet.

时间窗: 1st day, 30th day, 90th day, 120th day, 180th day

次要结局

  • Carious Lesion(1. 90 Days)

研究者

发起方
Inzpera Healthsciences Ltd A Subsidiary of Tata Industries Limited
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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