ABSTRACT
BACKGROUND: The authors report adverse events (AEs) related to the use of chlorhexidine gluconate mouthrinse in a clinical trial of the efficacy of periodontal treatment in older adults with diabetes. METHODS: Participants were U.S. veterans with uncontrolled diabetes (hemoglobin A(1c) value > or =8.5 percent) and periodontal disease. Treatment included periodontal scaling, 0.12 percent chlorhexidine lavage during ultrasonic scaling and use of chlorhexidine mouthrinse at home. RESULTS: Forty-four (31 percent) of 140 subjects reported having AEs. Most common were taste changes and tooth staining, sore mouth and/or throat, tongue irritation and wheezing/shortness of breath; the latter was reported more commonly before chlorhexidine use than after. Only body mass index greater than 30 was significantly related to AEs. CONCLUSIONS: AEs are common among subjects using chlorhexidine mouthrinse. Most AEs (taste change and staining) were resolved easily by subjects' discontinuing mouthrinse use and receiving dental prophylaxis. No serious AEs were reported. CLINICAL IMPLICATIONS: Clinicians should advise patients using chlorhexidine mouthrinse of possible side effects. If necessary, patients should discontinue mouthrinse use and obtain medical care. Careful monitoring of AEs in patients using chlorhexidine is warranted.
Subject(s)
Anti-Infective Agents, Local/adverse effects , Chlorhexidine/adverse effects , Diabetes Complications , Mouthwashes/adverse effects , Periodontal Diseases/prevention & control , Body Mass Index , Dental Scaling , Female , Follow-Up Studies , Glossitis/chemically induced , Humans , Male , Middle Aged , Pharyngitis/chemically induced , Respiratory Sounds/etiology , Self Care , Single-Blind Method , Stomatitis/chemically induced , Taste Disorders/chemically induced , Therapeutic Irrigation , Tooth Discoloration/chemically induced , Ultrasonic TherapyABSTRACT
OBJECTIVES: Report results of a randomized-clinical trial of the efficacy of periodontal care in the improvement of glycemic control in 165 veterans with poorly controlled diabetes over 4 months. METHODS: Outcomes were change in Haemoglobin A1c (HbA1c) in the Early Treatment versus untreated (Usual Care) groups and percent of participants with decreases in HbA1c. Analyses included simple/multiple variable linear/logistic regressions, adjusted for baseline HbA1c, age, and duration of diabetes. RESULTS: Unadjusted analyses showed no differences between groups. After adjustment for baseline HbA1c, age, and diabetes duration, the mean absolute HbA1c change in the Early Treatment group was -0.65% versus -0.51% in the Usual Care group (p=0.47). Adjusted odds for improvement by 0.5% in the Early Treatment group was 1.67 (95% confidence interval: 0.84, 3.34, p=0.14). Usual Care subjects were twice as likely to increase insulin from baseline to 4 months (20% versus 11%, p=0.12) and less likely to decrease insulin (1% versus 6%, p=0.21) than Early Treatment subjects. Among insulin users at baseline, more increased insulin in the Usual Care group (40% versus 21%, p=0.06). CONCLUSIONS: No significant benefit was found for periodontal therapy after 4 months in this study; trends in some results were in favour of periodontal treatment.
