Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. A common complication of diabetes is periodontal disease. Data show that diabetics have a higher prevalence and incidence of periodontal disease. Further, data suggest that improvements in periodontal status may also improve diabetes control. This project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics. We report here on recruitment, retention and measures of external and internal validity in the study. To examine internal validity of this study we compared assignment to relevant medical conditions in the control and experimental groups based on two data sources. This is a randomized clinical trial in diabetics receiving medical care in 4 VHA outpatient clinics in the Boston area. We include diabetic patients with HbA1c levels of >8.5% and > 8 teeth. Patients are randomly assigned to one of two groups: 1. experimental group- immediate periodontal evaluation and therapy; and 2. control group- periodontal evaluation and treatment 4 months after enrollment. The primary measure for the effectiveness of periodontal screening and therapy will be the comparison of the change in HbA1c levels at 4 months between the experimental and control groups. Secondary measures will include change in HbA1c after 1 year of therapy and measures of quality of life. To examine external validity, we compared basic health and demographic data between potential and randomized participants. To assess internal validity we compared demographic, clinical and oral quality of life data (self-report of oral health, GOHAI [Atchison,1990] and Satisfaction with Diabetes Care [Bradley,1994]) between study groups. To aid evaluation of internal validity, we determined the disease status of 132 veterans with poorly controlled diabetes based on the problem list data in Webtop and compared the assignment to those based on ICD-9-CM diagnostic codes from VA outpatient files from 1997 to the present. We computed the sensitivity (Sn), specificity (Sp), predictive value positive (PVP) and predictive value negative (PVN) for 40 medical conditions.

Condition	Treatment or Intervention
Diabetes Mellitus Poor glycemic control Peridontal disease	Drug: Doxycycline HCI 10mg po for 2 weeks  Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate

Genders Eligible for Study:  Both

Criteria

Patients must have diabetes mellitus, and HbAlc >9, >8 teeth, and CPITN scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need.

Massachusetts
      VA New England Health Care System, Bedford,  Massachusetts,  01730,  United States; Recruiting

Study ID Numbers:  DII 99-206
Record last reviewed:  October 2002
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00012688
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27