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Study design, recruitment, and baseline characteristics: the Department of Veterans Affairs Dental Diabetes Study
Author(s) -
Jones Judith A.,
Miller Donald R.,
Wehler Carolyn J.,
Rich Sharron,
Krall Elizabeth,
Christiansen Cindy L.,
Rothendler James A.,
Garcia Raul I.
Publication year - 2007
Publication title -
journal of clinical periodontology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.456
H-Index - 151
eISSN - 1600-051X
pISSN - 0303-6979
DOI - 10.1111/j.1600-051x.2006.00998.x
Subject(s) - randomized controlled trial , medicine , veterans affairs , randomization , physical therapy , diabetes mellitus , treatment and control groups , clinical trial , research design , social science , sociology , endocrinology
Objectives: We are conducting a clinical trial of the efficacy of periodontal therapy in the improvement of glycaemic control in veterans with poorly controlled diabetes. This report describes study design, recruitment and randomization and compares baseline characteristics of the sample frame with those randomized into study groups. Methods: Veterans with poorly controlled diabetes were randomized in two groups: immediate periodontal therapy (“early treatment”) or usual care followed by periodontal therapy (“deferred treatment”). Half of each group continued care for 12 months; the other half returned to their usual care. We studied baseline patient characteristics, self‐reported health measures, and clinical examination data. We examined means for continuous variables, frequencies for categorical variables and compared groups using t ‐tests and χ 2 tests (α=0.05 for both). Results: The 193 randomized participants were younger (58 years) and had slightly higher HbA1c (10.2%) than the 2534 non‐randomized participants (64 years, HbA1c =9.8%). The deferred treatment group was more likely than the early treatment group to have a history of stroke, transient ischaemic attacks, and less likely to be current or former smokers. Conclusions: The mechanism for randomization was largely successful in this study.