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.
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.
Imrey
P B
PB
University of Illinois, Urbana.
Chilton
N W
NW
Pihlstrom
B L
BL
Proskin
H M
HM
Kingman
A
A
Listgarten
M A
MA
Zimmerman
S O
SO
Ciancio
S G
SG
Cohen
M E
ME
D'Agostino
R B
RB
D000328:Adult; D000571:American Dental Association; D003257:Consumer Product Safety / Q000592:standards; D006801:Humans; D010518:Periodontitis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D014481:United States