Clinical trial NCT05986669: Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
Official title: Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Implant
Keywords: Dental Implants
Dental Prostheses
Safety and efficacy
Lead sponsor: DSP Industrial Ltda
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Implant success rate 6 months after the procedure
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events related to medical device or procedure
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Campo Largo
country: Brazil
facility: DSP Oral Clinica
state: Paraná
city: São Paulo
country: Brazil
facility: Universidade Estadual Paulista (UNESP)
state: SP
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Marcelo C Goiato, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DSP
name: Rafael Correira, PhD
role: PRINCIPAL_INVESTIGATOR
References: