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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986669
• Other study ID #: DSP_001
• Status: Recruiting
• Start date: August 18, 2023
• Est. completion date: May 2024

Study information

• Verified date: September 2023
• Source: DSP Industrial Ltda
• Contact: Marcelo C Goiato, PhD
• Phone: +55 18 99752-4700
• Email: m.goiato[@]unesp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: May 2024
• Est. primary completion date: February 2024
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant

Locations

Country	Name	City	State
Brazil	DSP Oral Clinica	Campo Largo	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
DSP Industrial Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant success rate 6 months after the procedure	Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain	6 months
Secondary	Adverse events related to medical device or procedure	Record of events that may happen	Through study completion, an average of 2 years