RANDOMIZED CONTROLLED TRIAL
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Effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox silicone tracheoesophageal voice prosthesis.

CONCLUSION: Daily application of a buccal bioadhesive slow-release nystatin tablet (100,000 IU per tablet) significantly increased the voice prosthesis lifetime in laryngectomized patients compared to conventional local cleaning of the prosthesis with an antimicrobial agent on a brush.

OBJECTIVE: To investigate the effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox tracheoesophageal voice prosthesis in post-laryngectomy patients.

MATERIAL AND METHODS: A buccal bioadhesive tablet, based on a spray-dried Amioca/Carbopol 974P mixture containing 10% (w/w) Carbopol 974P, was loaded with 100,000 IU of nystatin. Patients were included in the study when replacement of their voice prosthesis was required and were divided into three groups. Conventional daily local cleaning of the voice prosthesis by means of an oral nystatin suspension on a brush (Group 1; n = 7) was compared with application of one nystatin buccal bioadhesive tablet per day, after breakfast, on the gingiva above the upper canine (Group 2; n = 7). The control group (n = 5) used no antimicrobial agents. The lifetime of the prosthesis was followed and expressed in days.

RESULTS: The lifetime of the voice prosthesis was significantly increased in Group 2 compared to Group 1 (p < 0.05; paired t-test), indicating that sustained release of nystatin in the oral cavity, by means of erosion of the tablet over a period of approximately = 8 h, is more effective at preventing microbial colonization of the prosthesis than local cleaning.

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