Abstract
The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test–control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.
Highlights
Percutaneous osseointegrated titanium implants have been used to attach vibrating bone conduction devices to the temporal bone since 1977 [1]
Implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification
Severe complications are rare [4, 5]. The designs of these bone-anchored hearing implants have evolved to include wider diameters, based on the known advantages of wider implants in dentistry [7]. These 4.5-mm-wide implants provide a larger contact surface between the implant and the bone compared to the 3.75-mm-wide implants of the previous generation, which results in higher reported implant stability quotients (ISQ) and high implant survival rates [8, 9]
Summary
Percutaneous osseointegrated titanium implants have been used to attach vibrating bone conduction devices to the temporal bone since 1977 [1]. The designs of these bone-anchored hearing implants have evolved to include wider diameters, based on the known advantages of wider implants in dentistry [7]. These 4.5-mm-wide implants provide a larger contact surface between the implant and the bone compared to the 3.75-mm-wide implants of the previous generation, which results in higher reported implant stability quotients (ISQ) and high implant survival rates [8, 9]. Loading wider implants has been reported to be safe at 3 weeks after surgery [10]
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