Background: This study assessed the clinical performance of hydrophilic dental implants in a patient cohort with type 2 diabetes mellitus (T2DM). Methods: Subjects with T2DM of ≥2-years duration were allocated to either the well-controlled (WC; HbA1c ≤ 7.0%,) or poorly-controlled (PC; 7.5 < HbA1c < 10%) groups in a dual-center, prospective cohort study. Each subject received a single, titanium-zirconium (Ti-Zr) dental implant with a chemically-modified, hydrophilic (modSLA) surface in a posterior mandibular site. Postoperatively, subjects were followed at 1, 2, 4, 8, and 12-week intervals. Post-loading, subjects were followed at 3, 6, and 12-months. Clinical and radiographic parameters of implant success, and dental patient-reported outcomes were collected. Results: Twenty-one dental patients (NWC = 11; NPC = 10; mean age: 66.8 ± 7.5 years) were enrolled and the 1-year implant success rate was 100%. Peri-implant bone levels were stable with 0.15 ± 0.06 mm mean marginal loss at 1 year without significant inter-group differences (P = 0.79). Postoperative pain was minimal at 1-week, and OHIP-5 scores decreased significantly over time as compared with preoperative levels (P < 0.001) suggesting significant improvement in patient-perceived oral health following implant therapy. Conclusions: Elevated HbA1c levels > 7.5% did not compromise 1-year success rates, or oral health-related quality of life in PC patients receiving modSLA, Ti-Zr implants. Given that implant placement up to 10% HbA1c significantly enhanced oral health-related quality of life without complications or morbidity, the safety and efficacy of implants to improve oral function in T2DM is supported, even without ideal glycemic control.
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