Oral Surgical ProceduresNCT06154057
Retrospective Observational Study of Implant-supported Restorations With Dental Implants.
A study testing Dental Implants installed in an grafted area (sinus lifting), Dental Implants installed in an grafted area (ridge augmentation) and Dental Implants installed in an grafted area (extraction sites) in people with Oral Surgical Procedures, run by M3 Health at 1 site in Brazil.
Trial summary
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Surgical Procedures
- What is being tested?
- Dental Implants installed in an grafted area (sinus lifting), Dental Implants installed in an grafted area (ridge augmentation) and Dental Implants installed in an grafted area (extraction sites)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2019to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical parameters:
- Presence or absence of pain or tenderness
- Presence or absence of suppuration or exudation
- Presence or absence of mobility
- Prosthetic parameters
- Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).
Show all 18Show fewer
- Radiographic Parameters
- Presence or absence of peri-implant radiolucidity.
- maintenance and quality of the bone graft volume in the grafted area to each clinical indication: ridge augmentation, extraction sites (socket preservation or dental implant preparation/placement) and sinus lifting.
- Distance between the shoulder of the implant and the first visible bone contact (in mm).
- Presence or absence of technical complications such as fracture or loss of porcelain structures.
- Success Parameters
- Absence of pain or tenderness.
- Absence of suppuration or exudation.
- Clinical absence of implant mobility.
- Absence of peri-implant radiolucency.
- Minor loss of up to 1.5mm in the first year of function.
- Absence of mechanical or technical complications in the dental implant and in the prosthesis to the dental implants installed in an area grafted.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Observational Study of Implant-supported Restorations With Implants Produced by Additive Manufacturing
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.
- Conditions
- Oral Surgical Procedures
- Being tested
- Dental Implants installed in an grafted area (sinus lifting), Dental Implants installed in an grafted area (ridge augmentation), Dental Implants installed in an grafted area (extraction sites)
- Keywords
- Dental Implants, Synthetic Bone Graft, Additive Manufacture, Bone Loss, Success Rate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implants installed in an grafted area (sinus lifting)Procedure or surgery
Also called maxillary sinus lift
The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.
Dental Implants installed in an grafted area (ridge augmentation)Procedure or surgery
Also called Guided bone regeneration
The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.
Dental Implants installed in an grafted area (extraction sites)Procedure or surgery
Also called Guided bone regeneration
The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Dental Implants installed in an grafted area (sinus lifting) | Experimental | Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - sinus lifting. Receives: Procedure: Dental Implants installed in an grafted area (sinus lifting) |
| Dental Implants installed in an grafted area (ridge augmentation) | Experimental | Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - ridge augmentation. Receives: Procedure: Dental Implants installed in an grafted area (ridge augmentation) |
| Dental Implants installed in an grafted area (extraction sites) | Experimental | Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - extraction sites (socket preservation or dental implant preparation/placement). Receives: Procedure: Dental Implants installed in an grafted area (extraction sites) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
The main outcome is the survival rate (%) of successful implant-supported restoration after at least 1-year of occlusal loading (less than 0.5mm of bone loss)
Measured: 12 months
Secondary outcomes (2)
The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)
Survival rate (%) of successful implant-supported restorations (less than 0.5mm of bone loss) placed in different bone areas (pristine bone, grafted areas with Plenum Oss including maxillary sinus augmentation, guided bone regeneration for both vertical and horizontal augmentation, and extraction sockets).
Measured: 12 months
Rate of bone loss
A periapical x-ray will be performed at the implant placement region to check the bone level concerning the implant platform. Then, a vertical line will be drawn from the initial line to the bone level for measurement (mm). Standardized intraoral periapical radiographs will be obtained using a dental X-ray machine with a 35 cm long cone. The exposure parameter was 70 kV (Peak), 15mA, and 1/4s at a focus-sensor distance of 30cm. The X-rays will be captured with a digital camera and transferred to a personal computer. Image processing software will be used to store the scanned images. Subsequently, the images will be made available on a monitor and a linear measurement will be performed with software.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Dec 2019
- Primary completion30 Oct 2021
- Study completion30 Jul 2024
Why it stopped: The study was not terminated because we changed the methodology of the patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Surgical ProceduresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M3 Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Guarulhos
- Responsible party
- Sponsor
- Investigators
- Jamil A Shibli, PhD, Principal investigator, University of Guarulhos, UnG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154057
- Sponsor's protocol ID
- Plenum Oss 002
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study of Implant-supported Restorations With Implants Produced by Additive Manufacturing
- ClinicalTrials.gov ID
- NCT06154057
- Acronym / sponsor ID
- Plenum Oss 002
- Conditions
- Oral Surgical Procedures
- Keywords
- Dental Implants, Synthetic Bone Graft, Additive Manufacture, Bone Loss, Success Rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was not terminated because we changed the methodology of the patient recruitment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M3 HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Guarulhos
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 1 Dec 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.
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dental Implants installed in an grafted area (sinus lifting) | Experimental | Procedure: Dental Implants installed in an grafted area (sinus lifting)Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - sinus lifting. |
| Dental Implants installed in an grafted area (ridge augmentation) | Experimental | Procedure: Dental Implants installed in an grafted area (ridge augmentation)Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - ridge augmentation. |
| Dental Implants installed in an grafted area (extraction sites) | Experimental | Procedure: Dental Implants installed in an grafted area (extraction sites)Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - extraction sites (socket preservation or dental implant preparation/placement). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Presence or absence of pain or tenderness
- Presence or absence of suppuration or exudation
- Presence or absence of mobility
- Prosthetic parameters
- Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Implants installed in an grafted area (sinus lifting)Also: maxillary sinus liftThe patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months. | Procedure or surgery | Dental Implants installed in an grafted area (sinus lifting) |
| Dental Implants installed in an grafted area (ridge augmentation)Also: Guided bone regenerationThe patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months. | Procedure or surgery | Dental Implants installed in an grafted area (ridge augmentation) |
| Dental Implants installed in an grafted area (extraction sites)Also: Guided bone regenerationThe patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months. | Procedure or surgery | Dental Implants installed in an grafted area (extraction sites) |
Primary outcome
The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
Time frame: 12 months
The main outcome is the survival rate (%) of successful implant-supported restoration after at least 1-year of occlusal loading (less than 0.5mm of bone loss)
2 secondary outcomes
The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)
Time frame: 12 months
Rate of bone loss
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study was not terminated because we changed the methodology of the patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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. This study is not recruiting at the moment.
Jamil A Shibli, PhD principal investigator
University of Guarulhos, UnG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implants installed in an grafted area (sinus lifting), Dental Implants installed in an grafted area (ridge augmentation) and Dental Implants installed in an grafted area (extraction sites) in people with Oral Surgical Procedures, run by M3 Health at 1 site 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 18 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The study was not terminated because we changed the methodology of the patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp). (time frame: 12 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 20 Oct 2026.