Status:
RECRUITING
Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
Lead Sponsor:
DSP Industrial Ltda
Conditions:
Dental Implant
Eligibility:
All Genders
18-70 years
Brief 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 th...
Detailed Description
The study was designed as a prospective observational clinical record. This protocol will be submitted to the Ethics Committee and patients will be included only after ethics committee approval. All d...
Eligibility Criteria
Inclusion
- Patients of both sexes will be included;
- Regardless of race/color;
- Aged between 18 and 70 years;
- Who present partial or total tooth loss in a minimum period of three months;
- Healthy edentulous region;
- Good local and general health conditions, and psychological disposition;
- To undergo common oral surgery procedures, under local anesthesia, in addition to undergoing surgical procedures using one of the implant systems under evaluation (Standard Internal Hexagon (HIS); Large Internal Hexagon (HIL); Flexcone (FC); Flexcone Mini (FCM) and Morse Internal Hexagon (HIM).
Exclusion
- Patients who need bone grafting;
- Smokers who smoke 10 cigarettes/day or more;
- Individuals who make continuous use of bisphosphonates and anticoagulants, alcoholics, and/or users of illicit drugs
- Pregnant women;
- Diabetics with uncontrolled glycemia and individuals
- Patientes who were treated with radiotherapy.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05986669
Start Date
October 18 2023
End Date
August 1 2028
Last Update
April 17 2025
Active Locations (2)
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1
DSP Oral Clinica
Campo Largo, Paraná, Brazil, 83601-620
2
Universidade Estadual Paulista (UNESP)
São Paulo, São Paulo, Brazil, 01049-010