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

Launched by DSP INDUSTRIAL LTDA · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of different types of dental implants made by DSP. Dental implants are artificial tooth roots that are placed in the jawbone to support replacement teeth, and they can greatly improve a person's ability to chew, speak, and feel confident. The trial aims to include 1,053 patients who have lost some or all of their teeth and are in good health. To participate, individuals must be between 18 and 70 years old, have a healthy area in their mouth where the implant will be placed, and be willing to undergo a common dental procedure under local anesthesia.

Participants in this study can expect to receive one of the dental implant systems being tested and will be monitored for how well the implants integrate with their jawbone over time, as well as any potential side effects. Importantly, people who smoke heavily, have certain medical conditions, or are pregnant are not eligible to join. The goal of the study is to ensure that these dental implants are safe and effective for patients, ultimately helping improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.