Dental ImplantNCT05986669
Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
An observational study of Dental Implant, run by DSP Industrial Ltda at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Implant
- How many people
- 700 participants
- Where
- 2 sitesBrazil
- Study dates
- 18 Oct 2023to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
DSP Oral Clinica
Campo Largo, Paraná, 83601-620
Rafael Correira, PhD, +1 (734) 276-0984, rafaelcorreira14@gmail.com
Emily Santana, Dra, +55 41 9516-4553, emilyqbsantana@gmail.com
- Recruiting
Universidade Estadual Paulista (UNESP)
São Paulo, São Paulo, 01049-010
Marcelo C Goiato, PhD, +551899752-4700, m.goiato@unesp.br
Ruan Barra, MSc, +55348843-4741, ruan_d.barra@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Dental Implant
- Keywords
- Dental Implants, Dental Prostheses, Safety and efficacy
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success rate 6 months after the procedure
Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain
Measured: 6 months
Secondary outcomes (1)
Adverse events related to medical device or procedure
Record of events that may happen
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DSP Industrial Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo C Goiato, PhD, Principal investigator, UPECLIN HC FM Botucatu UnespRafael Correira, PhD, Principal investigator, DSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986669
- Sponsor's protocol ID
- DSP_001
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
- ClinicalTrials.gov ID
- NCT05986669
- Acronym / sponsor ID
- DSP_001
- Conditions
- Dental Implant
- Keywords
- Dental Implants, Dental Prostheses, Safety and efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- DSP Industrial LtdaIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant success rate 6 months after the procedure
Time frame: 6 months
Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain
1 secondary outcome
Adverse events related to medical device or procedure
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelo C Goiato, PhD principal investigator
UPECLIN HC FM Botucatu Unesp
Rafael Correira, PhD principal investigator
DSP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant, run by DSP Industrial Ltda at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo C Goiato, PhD (+55 18 99752-4700, m.goiato@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success rate 6 months after the procedure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.