RECOMMENDED REVISIONS TO AMERICAN-DENTAL-ASSOCIATION GUIDELINES FOR ACCEPTANCE OF CHEMOTHERAPEUTIC PRODUCTS FOR GINGIVITIS CONTROL

被引:29
作者
IMREY, PB
CHILTON, NW
PIHLSTROM, BL
PROSKIN, HM
KINGMAN, A
LISTGARTEN, MA
ZIMMERMAN, SO
CIANCIO, SG
COHEN, ME
DAGOSTINO, RB
FISCHMAN, SL
FLEISS, JL
GUNSOLLEY, JC
KENT, RL
KILLOY, WJ
LASTER, LL
MARKS, RG
VARMA, AO
机构
[1] UNIV ILLINOIS, DEPT MED INFORMAT SCI, URBANA, IL 61801 USA
[2] UNIV ILLINOIS, DEPT COMMUNITY HLTH STAT, URBANA, IL 61801 USA
[3] UNIV ILLINOIS, CTR RES ORAL MOLEC BIOL, URBANA, IL 61801 USA
[4] COLUMBIA UNIV, SCH DENT & ORAL SURG, NEW YORK, NY USA
[5] COLUMBIA UNIV, DIV BIOSTAT, NEW YORK, NY USA
[6] UNIV MINNESOTA, MINNESOTA CLIN DENT RES CTR, MINNEAPOLIS, MN 55455 USA
[7] EASTMAN DENT CTR, DIV BIOSTAT, ROCHESTER, NY USA
[8] NIDR, EPIDEMIOL & ORAL DIS PREVENT PROGRAM, BETHESDA, MD 20892 USA
[9] UNIV PENN, EPIDEMIOL SECT, PHILADELPHIA, PA 19104 USA
[10] UNIV TEXAS, MD ANDERSON CANC CTR, DEPT BIOMATH, HOUSTON, TX 77030 USA
[11] SUNY BUFFALO, DEPT PERIODONTOL, BUFFALO, NY USA
[12] SUNY BUFFALO, DEPT ORAL MED, BUFFALO, NY USA
[13] USN, DENT RES INST, GREAT LAKES, IL USA
[14] BOSTON UNIV, DEPT MATH, BOSTON, MA 02215 USA
[15] VIRGINIA COMMONWEALTH UNIV, DEPT PERIODONT, RICHMOND, VA USA
[16] FORSYTH DENT CTR, BOSTON, MA 02115 USA
[17] UNIV MISSOURI, DEPT PERIODONT, KANSAS CITY, MO 64110 USA
[18] UNIV FLORIDA, DEPT STAT, DIV BIOSTAT, GAINESVILLE, FL 32611 USA
[19] SUNY STONY BROOK, DEPT PREVENT MED, STONY BROOK, NY 11794 USA
[20] UNIV PENN, DEPT PERIODONT, PHILADELPHIA, PA 19104 USA
关键词
GINGIVITIS; AMERICAN DENTAL ASSOCIATION; EFFICACY; CLINICAL TRIALS;
D O I
10.1111/j.1600-0765.1994.tb01225.x
中图分类号
R78 [口腔科学];
学科分类号
1003 ;
摘要
This paper presents suggested revisions to the American Dental Association's 1985 guidelines for acceptance of anti-gingivitis chemotherapeutic agents. The areas of study design, choice and quality control of clinical gins measurements, statistical analysis, and minimum strength of effect, are addressed. The revisions articulate certain aspects of study design which were implicit in the 1985 guidelines, clarify language on cross-over designs and independence of studies, and recommend use of a United States population in at least one trial supporting a product. Separate recording and analysis of a product's effect on gingival bleeding is proposed, and quality control of clinical measurements receives enhanced emphasis. Modestly elaborated statistical reporting guidelines and strengthened approval criteria, based on size of estimated effect as well as statistical significance, are advocated.
引用
收藏
页码:299 / 304
页数:6
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