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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant

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 data will be collected from procedures performed in actual clinical practice. Specific surgical interventions will not be performed for the purposes of this study, since this is an observational study.

After the surgeries, the patients will be followed up for one year. The patient's data will be collected on five visits scheduled for assessment of the outcomes of the study. (Baseline, T0, T90, T180 and T360).

The forecast for the study end is 24 months after the first inclusion.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Marcelo C Goiato, PhD; Phone Number: +55 18 99752-4700; Email: m.goiato@unesp.br
• Study Contact Backup: Name: Ruan Barra, MSc; Phone Number: +55 34 8843-4741; Email: ruan_d.barra@hotmail.com

Study Locations

• Brazil
  • Paraná
    • Campo Largo, Paraná, Brazil, 83601-620
      • Recruiting
      • DSP Oral Clinica
      • Contact: Rafael Correira, PhD; Phone Number: +1 (734) 276-0984; Email: rafaelcorreira14@gmail.com
      • Contact: Emily Santana, Dra; Phone Number: +55 41 9516-4553; Email: emilyqbsantana@gmail.com
  • SP
    • São Paulo, SP, Brazil, 01049-010
      • Recruiting
      • Universidade Estadual Paulista (UNESP)
      • Contact: Marcelo C Goiato, PhD; Phone Number: +551899752-4700; Email: m.goiato@unesp.br
      • Contact: Ruan Barra, MSc; Phone Number: +55348843-4741; Email: ruan_d.barra@hotmail.com
      • Principal Investigator: Marcelo C Goiato, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The patients to study will be recruited from the site UNESP and DSP Training Center according to the inclusion and exclusion criteria shown in the protocol.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant success rate 6 months after the procedure	Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to medical device or procedure	Record of events that may happen	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: DSP Industrial Ltda
• Investigators: Principal Investigator: Marcelo C Goiato, PhD, UPECLIN HC FM Botucatu Unesp; Principal Investigator: Rafael Correira, PhD, DSP

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Dental Implants; Safety and efficacy; Dental Prostheses
• Other Study ID Numbers: DSP_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No