INTRODUCTION: The majority of orthodontic patients present with plaquebiofilm and related manifestations in the early stages of active fixed orthodontic appliance use. AIMS: To evaluate the effects of a slow-delivery chlorhexidine:beta-cyclodextrin (Cx:beta-Cd) gel compared with those of free Cx free formulations on clinical parameters in patients undergoing treatment with fixed orthodontic appliances. METHODS: Patients aged 12-18 years received prophylaxis and scaling and were randomised to treatment groups in a double-blinded manner. They were treated with Cx:beta-Cd, Cx, or placebo gel for 15 or 30 days. Bleeding on probing and the visible plaque index were recorded, and gingival crevicular fluid samples were collected for the assessment of cytokine expression. RESULTS: At 15 days, the Cx:beta-Cd group exhibited significantly less BOP than did the Cx and control groups (P < 0.001; n = 116). At 15 days, notable decreases in tumour necrosis factor-alpha and interferon-gamma expression, as well as a substantial increase in interleukin-10 expression, were observed in the Cx:beta-Cd and Cx groups relative to the control group (P < 0.05). The molecular encapsulation gel resulted in greater saliva Cx concentrations than did the free Cx gel released concentrations of 800 ng g(-1). CONCLUSION: Cx:beta-Cd gel is effective for the slow delivery of Cx, improving the gingival health of adolescents undergoing orthodontic treatment. CLINICAL RELEVANCE: A single application of encapsulated Cx gel, was a more effective antiseptic than a free Cx application in fixed orthodontice appliance wearers.
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