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Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data

NCT05986669 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-04-17

No results posted yet for this study

Summary

Studies on facial trauma are essential to establish an appropriate treatment approach, assess the ability to restore functions and seek ways of prevention. Among craniofacial injuries, fractures of the zygomatic complex are the most frequent, occurring in 25-30% of cases. Statistical analysis shows that traffic collisions (41%), domestic accidents (23%) and sports accidents (18%) are the main causes. Dental implants have emerged as a rehabilitative alternative for these patients, being considered the first choice for individuals who have lost all or part of their dental arch. In addition to providing a better quality of life, it reconstitutes masticatory function, self-esteem and phonetics. Understanding the importance of evaluating the performance of dental implants and considering the responsibility for the health of patients, there was a need to evaluate the effectiveness and safety of the Standard Internal Hexagon Implant System (HIS), Large Internal Hexagon (HIL), Flexcone (FC) , Mini Flexcone (FCM) and Morse Internal Hexagon, from DSP. In this prospective study, 1053 implants will be included. To be eligible, patients can be of both sexes, be 18 years of age or older, any race and gender, have partial or total tooth loss, present good local and general health conditions and psychological disposition to undergo common oral surgery procedures. under local anesthesia and healthy edentulous region as they will be subsequently submitted to surgical procedures using the DSP Implant System. Electronic data collection and management will be performed using the REDCap software, with categorical variables being described as absolute and relative frequencies and continuous ones being tested for normality using the Shapiro-Wilk test. Osseointegration percentages between 30 days and 6 months will also be calculated. Other efficacy outcomes and incidence of adverse events will be estimated with 95% confidence intervals. As a result, from the strengthening of product evaluation actions, it is expected to demonstrate that the implant has a good safety and efficacy profile to be offered to the population.

Conditions

  • Dental Implant

Sponsors & Collaborators

  • DSP Industrial Ltda

    lead INDUSTRY

Principal Investigators

  • Marcelo C Goiato, PhD · UPECLIN HC FM Botucatu Unesp

  • Rafael Correira, PhD · DSP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-12-31
Completion
2028-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05986669 on ClinicalTrials.gov