Proposed guidelines for American Dental Association acceptance of products for professional, non-surgical treatment of adult periodontitis. Task Force on Design and Analysis in Dental and Oral Research.

Proposed guidelines for American Dental Association acceptance of products for professional, non-surgical treatment of adult periodontitis. Task Force on Design and Analysis in Dental and Oral Research.
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美国牙科协会接受专业、非手术治疗成人牙周炎产品的拟议指南。

DOI:
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发表时间:
1994
影响因子:
3.5
通讯作者:
Neal W. Chilton
Neal W. Chilton
中科院分区:
医学3区
文献类型:
--
作者:
Neal W. Chilton

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指南建议确定产品的功效,以补充洁治和根面平整术在专业,非手术治疗成人牙周炎。它们来自一个扩展的过程,包括牙龈炎和牙周炎临床试验会议,随后的研讨会,以及牙周研究界的工业,学术,专业和政府成员对两个草案的评论。在基础研究设计、受试者和牙周部位选择、临床管理、结果变量的选择、统计总结和分析以及验收标准等广泛领域提出了建议。还提供了突出的不同意见,并说明了在此采取立场的理由。为今后可能制定的关于初级预防或非处方使用产品的准则或确定竞争产品的优越性或等效性的准则奠定了基础。然而,在这些领域提出负责任和广泛接受的建议之前,还需要进一步探讨一些问题。这里建议的指导方针是为了形成一个不断发展的文件,而不是一个静态的标准的基础。有人建议,他们经常进行审查,在改善牙周研究的技术,并出现代表牙周治疗新方法的产品。
Guidelines are suggested for determining efficacy of products to supplement scaling and root planing in professional, non-surgical treatment of adult periodontitis. They result from an extended process including a conference on clinical trials in gingivitis and periodontitis, a subsequent workshop, and commentary from industrial, academic, professional and governmental members of the periodontal research community on two drafts. Recommendations are made in the broad areas of basic study design, subject and periodontal site selection, clinical management, choice of outcome variables, statistical summarization and analysis, and criteria for acceptance. Prominent dissenting views, with justifications for positions taken here, are also provided. Groundwork is laid for possible future guidelines addressing products for primary prevention or over-the-counter uses, or for determining superiority or equivalence of competing products. However, issues are identified which require further exploration before responsible and widely acceptable recommendations can be made in these areas. The guidelines suggested here are meant to form the basis of an evolving document rather than a static standard. It is suggested that they be reviewed frequently in the light of improvement in the technology available for periodontal research, and the emergence of products representing new approaches to periodontal therapy.
针对牙周炎研究的设计问题。
DOI: 10.1111/j.1600-0765.1992.tb01704.x
发表时间: 1992
影响因子: 3.5
作者:
Page,RC;DeRouen,TA
通讯作者: DeRouen,TA