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Periodontal Care and Glycemic Control in Diabetes Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Periodontal Care and Glycemic Control in Diabetes conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Periodontal Care and Glycemic Control in Diabetes Clinical research trials and Periodontal Care and Glycemic Control in Diabetes healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Periodontal Care and Glycemic Control in Diabetes. Periodontal Care and Glycemic Control in Diabetes Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Periodontal Care and Glycemic Control in Diabetes clinical trial. Participants typically obtain the most effective healthcare available for their Periodontal Care and Glycemic Control in Diabetes condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Periodontal Care and Glycemic Control in Diabetes  Periodontal Care and Glycemic Control in Diabetes
Periodontal Care and Glycemic Control in Diabetes
For Condition: Peridontal disease,Poor glycemic control,Diabetes Mellitus
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service,Colgate-Periogard-Dentsply
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 300
Location and Contact Information:
VA New England Health Care System *Recruiting*
Bedford, Massachusetts, 01730
United States
Recruiting Judith Jones (781) 687-3161
Additional Information:
Study ID Numbers: DII 99-206;
Study Start Date: January 2000
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012688
Other Diabetes Mellitus Studies:
1. Periodontal Care and Glycemic Control in Diabetes
Related Studies:
Other Diabetes Mellitus Clinical Trials
Other Massachusetts Clinical Trials
Other Bedford Clinical Trials
Periodontal Care and Glycemic Control in Diabetes
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