Evaluation of safety and efficacy of locally developed dental implants: A noninferiority randomized controlled trial

• DOI: 10.1016/j.prosdent.2021.12.027
• Publication Date: 2022-03-09T05:45:12Z
• Authors: Mahesh Verma; Farrukh Faraz; Smiti Bhardwaj; Abhinav Sood
• Keywords: Implant stability quotient; Dental prosthesis

Statement of problemVarious dental implants are available in India, but imported devices expensive; an affordable locally produced implant system would be beneficial.PurposeThe purpose this noninferiority randomized controlled trial was to compare the safety and efficacy a developed those established with similar microsurface characteristics.Material methodsA total 136 participants 201 partially edentulous sites, aged 18 65 years, were enrolled trial, 134 sites receiving test 67 control (n ratio, 2:1). The received delayed submerged healing protocol loaded 3 6 months after surgery. Maximum insertion torque (IT) recorded during surgery, stability quotient (ISQ) evaluated on day surgery at second-stage procedure. mean crestal bone loss (MCBL) measured periapical radiographs prosthetic placement (baseline) 12 loading. primary measure outcome survival rate, secondary evaluation intergroup difference MCBL baseline, months, months.ResultsA 127 61 for follow-up 1 year prosthesis placement. At end groups demonstrated rate 97% 100%, respectively. significant between 2 baseline (P<.05). However, not significantly different (P>.05).ConclusionsThe group fell within previously assumed 10% margin. Therefore, null hypothesis accepted noninferior sample allocation ratio 2:1.