Ceravital versus plastipore in tympanoplasty: a randomized prospective trial.

The hearing results and extrusion rates for ossicular chain reconstruction using a new material called Ceravital, a bioactive glass ceramic, were compared with those for Plastipore, a porous polyethylene that is our standard for synthetic materials. Our null hypothesis was that the results of the two materials were similar. A Ceravital or a Plastipore prosthesis was randomly assigned to 112 consecutive patients. We had 6-month follow-up on 100 patients and 3-year follow-up on 80 patients. The average air-bone gap at 4,000 Hz was 6 dB less with Plastipore than with Ceravital (p = .036). Patients were twice as likely to have an air-bone gap of 15 dB or less with Plastipore than with Ceravital (40% versus 21%; p = .061). Two of the 38 patients with Ceravital prostheses had a late hearing-result failure due to resorption of the prosthesis material. The materials had similar extrusion rates. We rejected our null hypothesis. The Plastipore group had better hearing results than did the Ceravital group.

RCT Entities:   Population Interventions Outcomes