Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants

Condition(s) studied

Investigational drug(s) / intervention(s)

TITANIUM IMPLANT: The surgical technique, type of implant installed, and selected prosthetic components will follow the manufacturer's recommendations (SIN Implant System, São Paulo, Brazil), always considering treatment options for optimal patient rehabilitation.

Study summary

The success of rehabilitation with osseointegrated implants is associated with numerous factors, including patient characteristics, installed implants, proper planning, and the prosthetic connections used. In the long term, success is closely related to the clinical radiographic follow-up of the implanted region and the identification of intrinsic or extrinsic factors that may interfere with implant survival. Therefore, the objective of this study is to evaluate, through clinical and radiographic analysis, the peri-implant tissues and prosthetic connections of research participants rehabilitated with osseointegrated implants at the Implant Dentistry Clinic of the Federal Fluminense University, over a period of 5 years. This will be a double-blind longitudinal study. A total of 148 research participants will be selected, respecting the inclusion criteria: completion of surgical-prosthetic planning by the Implant Dentistry Clinic team at UFF, including osseointegrated implants and prosthetic components manufactured by SIN Implant System (São Paulo, Brazil); agreeing to and signing the informed consent form, being willing to be monitored for a period of 5 years; systemically healthy patients who do not use antiresorptive and antiangiogenic drugs; patients with a plaque index \<20% (Ainamo \& Bay 1975) and bleeding on probing \<20% (Muhlemann \& Son 1971) at the start of the study. Participants will undergo clinical and radiographic analysis of peri-implant tissues and prosthetic connections at the following intervals: up to 7 days after implant installation (Time 0), at the time of prosthesis installation (Time 1), 6 months after prosthesis installation (Time 2), and 1 to 5 years after prosthesis installation (Times 3, 4, 5, 6, and 7, respectively). It is expected that this longitudinal study will lead to a better understanding of the factors influencing peri-implant bone loss and long-term success.

Eligibility

Primary outcome measure(s)

• PRIMARY IMPLANT STABILITY — From enrollment to the end of treatment at 6 months
  Data on the clinical and radiographic characteristics of the different installed implants and the short-term stability of their prosthetic connections will be obtained. Over the years of evaluation, there may be better recognition of the factors influencing peri-implant bone loss and long-term success.

Trial sites (1)

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