Study design, recruitment, and baseline characteristics: the Department of Veterans Affairs Dental Diabetes Study
: Judith A. Jones
: Blackwell Synergy
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 (Ã¢â‚¬ËœÃ¢â‚¬Ëœearly treatmentÃ¢â‚¬â„¢Ã¢â‚¬â„¢) or usual care followed by
periodontal therapy (Ã¢â‚¬ËœÃ¢â‚¬Ëœdeferred treatmentÃ¢â‚¬â„¢Ã¢â‚¬â„¢). 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 w2 tests (a50.05 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
59.8%). 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
Conclusions: The mechanism for randomization was largely successful in this study.
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