title: The effects of simple interventions on tooth mortality: findings in one trial and implications for future studies.
abstract: The purpose of this report was to use a particular clinical trial, the Preventive Geriatric Trial (PGT), as a starting point to discuss whether treatment efficacy can be evaluated by means of tooth mortality. In the PGT, 296 subjects were recruited and randomly assigned to five treatment groups: (1) usual procedures (UP); (2) UP + a cognitive-behavioral intervention (CB); (3) UP + CB + weekly chlorhexidine rinse (CHX); (4) UP + CB + CHX + semi-annual fluoride varnish (F); and (5) UP + CB + CHX + F + semi-annual prophylaxis, including scaling (P). Exploratory analyses revealed that tooth mortality after the 1st year was lower in treatment groups 3, 4, and 5 than in groups 1 and 2. A one-year exposure resulted in a 45% reduction in tooth mortality (p < 0.05); a two-year exposure resulted in a 59% reduction (p-value < 0.04). The PGT findings suggested that it is possible to design trials based on clinically relevant endpoints, such as tooth mortality. For the detection of moderate treatment effects, such trials could take the form of Large, Simple Trials (LST), where many subjects are recruited with minimally restrictive entry criteria, and data are collected only on essential baseline characteristics and tooth mortality. LSTs have provided "reliable answers to important clinical questions" for other chronic diseases, and several arguments suggest that they could play a similar critical role in dental research: (1) Periodontitis and caries are among the most common and costly chronic diseases affecting humans, and the identification of even moderately effective treatments by LSTs can have a large socio-economic impact; (2) the identification of low-cost widely practicable treatments that lend themselves to be investigated in LSTs is likely to benefit more people than the identification of high-cost complex treatments; and (3) tooth mortality is simple to assess and more relevant than the unvalidated surrogate endpoints that have largely failed for more than 20 years to provide reliable answers to certain controversial issues regarding treatment efficacy. The cost of not reliably establishing the safety and the efficacy of treatments may be far greater than the cost of conducting LSTs.
authors.affiliation: Department of Dental Public Health Sciences, School of Dentistry, University of Washington, Seattle 98195, USA.
authors.forename: P P
authors.initials: PP
authors.lastname: Hujoel
authors.forename: L V
authors.initials: LV
authors.lastname: Powell
authors.forename: H A
authors.initials: HA
authors.lastname: Kiyak
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000890:Anti-Infective Agents / Q000627:therapeutic use; D001521:Behavior Therapy; D002710:Chlorhexidine / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods; D016321:Dental Care for Aged / Q000191:economics / Q000379:methods*; D003731:Dental Caries / Q000628:therapy; D003777:Dental Prophylaxis; D018865:Dental Research / Q000191:economics / Q000379:methods; D005260:Female; D005460:Fluorides, Topical / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010510:Periodontal Diseases / Q000628:therapy; D016016:Proportional Hazards Models; D012044:Regression Analysis; D012107:Research Design; D016019:Survival Analysis; D016388:Tooth Loss / Q000517:prevention & control*
chemical_list: D000890:Anti-Infective Agents; D005460:Fluorides, Topical; D002710:Chlorhexidine