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

NCT05986669 | Recruiting DMC

• 1 other identifier: DSP_001
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

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 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

Keywords

Dental Implants; Dental Prostheses; Safety and efficacy

Outcome Measures

Primary Outcomes (1)

• Implant success rate 6 months after the procedure

  Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain

  6 months

Secondary Outcomes (1)

• Adverse events related to medical device or procedure

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• DSP Industrial Ltda: lead

Study Sites (2)

DSP Oral Clinica

Campo Largo, Paraná, 83601-620, Brazil

RECRUITING

Universidade Estadual Paulista (UNESP)

São Paulo, São Paulo, 01049-010, Brazil

RECRUITING

Study Officials

• Marcelo C Goiato, PhD

  UPECLIN HC FM Botucatu Unesp

  PRINCIPAL INVESTIGATOR

• Rafael Correira, PhD

  DSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo C Goiato, PhD

CONTACT

+55 18 99752-4700; m.goiato@unesp.br

Ruan Barra, MSc

CONTACT

+55 34 8843-4741; ruan_d.barra@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 14, 2023
• Study Start: October 18, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 17, 2025

Record last verified: 2024-08

Locations

BR (2)