Evaluating the safety and effectiveness of DSP Dental Implant Systems
Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
This study is testing how safe and effective different DSP Dental Implant Systems are for people who have lost some or all of their teeth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | DSP Industrial Ltda Industry-sponsored |
| Locations | 2 sites (Campo Largo, Paraná and 1 other locations) |
| Trial ID | NCT05986669 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of various DSP Dental Implant Systems in patients with partial or total tooth loss. It involves collecting real-world data from patients undergoing common oral surgery procedures over a one-year follow-up period. Patients will be monitored through five scheduled visits to evaluate outcomes related to the dental implants. The study will adhere to ethical guidelines and will only include patients after receiving approval from the Ethics Committee.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with partial or total tooth loss who are in good health and can undergo oral surgery.
Not a fit: Patients requiring bone grafting, smokers, those on certain medications, pregnant women, and individuals with uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients requiring dental implants by ensuring their safety and effectiveness.
How similar studies have performed: Other studies have shown positive outcomes with similar dental implant approaches, indicating a potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Campo Largo, Paraná and 1 other locations
- DSP Oral Clinica — Campo Largo, Paraná, Brazil (Recruiting)
- Universidade Estadual Paulista (UNESP) — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Marcelo C Goiato, PhD — UPECLIN HC FM Botucatu Unesp
- Study coordinator: Marcelo C Goiato, PhD
- Email: m.goiato@unesp.br
- Phone: +55 18 99752-4700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.