2043 Randomization and baseline characteristics: The VA Dental Diabetes Study (VA-DDS)
J.A. JONES, VA Medical Center, Bedford & Boston University Goldman School of Dental Medicine and Public Health, MA, USA, R.I. GARCIA, Boston University Goldman School of Dental Medicine and VA Boston Healthcare System, MA, USA, C.J. WEHLER, VA Medical Center, Bedford & Boston University Goldman School of Dental Medicine, MA, USA, S.E. RICH, VA Medical Center, Bedford, MA, USA, D.R. MILLER, VA Medical Center, Bedford & Boston, and Boston University School of Public Health, MA, USA, J. ROTHENDLER, VA Medical Center, Bedford & Boston University, MA, USA, E.A. KRALL, Boston University School of Dental Medicine, MA, USA, and C.L. CHRISTIANSEN, VA Bedford, MA and Boston University, MA, USA

Objectives: Successful randomization is key to the validity of a clinical trial. The purpose of this paper is to (1) report on the randomization in a clinical trial of the efficacy of screening and clinical therapy (ultrasonic and hand periodontal scaling with systemic doxycycline and 0.12%chlorhexidine rinse) in the improvement of glycemic control in poorly controlled diabetics, and (2) examine the relationships of selected explanatory variables to baseline HbA1c. Methods: We collected data via survey (SES, use of dental care, self-reported general and oral health, stress, limitations in physical activity, duration of diabetes, BMI, smoking and alcohol use) and clinical examination (number of teeth, root tips, CPITN, exudate on probing and palpation, Gingival Index, Plaque Index, periodontal probing, gingival recession, tooth mobility). We examined means for continuous variables, frequencies for categorical variables, compared treatment groups (treatment versus control group) using t-tests and chi square tests, and used simple regression to examine the relationships between baseline HbA1c and explanatory parameters (alpha=0.05). Results: For the first 52 participants randomized, overall mean age was 58+/-10, 6% were female, mean HbA1c was 10.6+/-1.3, BMI was 32kg/m2+/-0.7, 63% used dental care in the last 12 months, mean number of teeth was 22+/-6 and 63% rated their oral health as fair or poor. Half (51%) were former smokers, 21% were current and 27%, never smoked. There were no differences in any of the survey or examination parameters between treatment groups. Simple regression showed that only number of teeth was related to HbA1c level (R2=0.17, p=0.011). Conclusions: These data suggest that the mechanism for randomization was successful in this study. Supported by VA HSR&D QUERI DII-99.206 and NIH K24 DE00419. judjones@bu.edu.

Seq #191 - Systemic Health Issues in Geriatric Oral Health
11:00 AM-12:15 PM, Friday, 8 March 2002 San Diego Convention Center Exhibit Hall C

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