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Evaluation of safety and efficacy of locally developed dental implants: A noninferiority randomized controlled trial
Mahesh Verma1, Farrukh Faraz2, Smiti Bhardwaj3
1Professor Emeritus, Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, New Delhi, India; Vice Chancellor, G.G.S.I.P.U., Delhi, India.
Statement Of Problem:
Various dental implants are available in India, but imported devices are expensive; an affordable locally produced dental implant system would be beneficial.
Purpose:
The purpose of this noninferiority randomized controlled trial was to compare the safety and efficacy of a locally developed dental implant system to those of an established imported dental implant system with similar microsurface characteristics.
Material And Methods:
A total of 136 participants with 201 partially edentulous sites, aged 18 to 65 years, were enrolled in the trial, with 134 sites receiving test implants and 67 sites control implants (n ratio, 2:1). The implants received a delayed submerged healing protocol and were loaded 3 to 6 months after surgery. Maximum insertion torque (IT) was recorded during the implant surgery, and the implant stability quotient (ISQ) was evaluated on the day of surgery and at the second-stage procedure. The mean crestal bone loss (MCBL) was measured on periapical radiographs at prosthetic placement (baseline) and at 6 months and 12 months after loading. The primary measure of outcome was the implant survival rate, and the secondary measure of evaluation was the intergroup difference in MCBL at baseline, 6 months, and 12 months.
Results:
A total of 127 test and 61 control implant sites were available for follow-up 1 year after prosthesis placement. At the end of 12 months, the test and control implant groups demonstrated a survival rate of 97% and 100%, respectively. The MCBL difference was significant between the 2 groups at baseline (P<.05). However, at 6 and 12 months, the difference between the test and control groups was not significantly different (P>.05).
Conclusions:
The survival rate of the test group fell within the previously assumed 10% noninferiority margin. Therefore, the null hypothesis was accepted for the trial, and the locally developed implants were noninferior to the imported implants at a sample allocation ratio of 2:1.
