Periodontal DiseasesNCT07405918
3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation
An observational study of Periodontal Diseases and Periodontal Bone Loss, run by University of Guarulhos.
Trial summary
This study will evaluate the behavior of the implant-supported restorations (prosthesis) placed into the areas grafted with the 3D printed customized bone (personalized graft produced to fit a specific bone defect), as well as the volume contraction of the printed bone. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Bone Loss
- What is being tested?
- Clinical evaluation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2026
- How long will I take part?
- 6 Years
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This prospective cohort study will evaluate the peri-implant conditions of patients who received regenerative procedures using 3D-printed blocks at the UnG Clinic. To this end, participants will be selected from the UnG graduate clinic who received the regenerative treatment using 3D-printed blocks between 2019 and 2025. Participants selected for the study must sign the Informed Consent Form (ICF) after a verbal and written explanation of the project. Subjects will receive oral hygiene instruction and professional prophylaxis prior to clinical examinations.
Who may be able to join
- Systemically healthy individuals
- over 18 years of age
- Subjects that received regenerative surgical treatment by customized 3D printed blocks.
- Subjects must agree to participate in the study and agree to sign the Informed Consent.
Who cannot join
- Subjects with ilness that avoid their presence to the clinical evaluation
- ISubjects who have lost the customized blocks
- Subjects who do not agree to participate in the study will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will evaluate the behavior of the implant-supported restorations (prosthesis) placed into the areas grafted with the 3D printed customized bone (personalized graft produced to fit a specific bone defect), as well as the volume contraction of the printed bone.
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Being tested
- Clinical evaluation
- Keywords
- Personalized bone graft, 3D printed customized bone block, Guided Bone Regeneration, Personalized Medicine
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
Clinical parmeters and radiographical analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Clinical Parameter of the implants Placed in the Grafted area
Marginal Bone Loss < 2mm
Measured: 5 years
Secondary outcomes (1)
Bone Graft Volume Alteration
Tomographic Volumetric Measurement (mm3) of the 3D printed graft after a period ranged between 1 to 6 years
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- University of Guarulhos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamil awad shibli, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405918
- Sponsor's protocol ID
- Guaruhos University
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation
- ClinicalTrials.gov ID
- NCT07405918
- Acronym / sponsor ID
- Guaruhos University
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Keywords
- Personalized bone graft, 3D printed customized bone block, Guided Bone Regeneration, Personalized Medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GuarulhosUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (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 study will evaluate the behavior of the implant-supported restorations (prosthesis) placed into the areas grafted with the 3D printed customized bone (personalized graft produced to fit a specific bone defect), as well as the volume contraction of the printed bone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective cohort study will evaluate the peri-implant conditions of patients who received regenerative procedures using 3D-printed blocks at the UnG Clinic. To this end, participants will be selected from the UnG graduate clinic who received the regenerative treatment using 3D-printed blocks between 2019 and 2025. Participants selected for the study must sign the Informed Consent Form (ICF) after a verbal and written explanation of the project. Subjects will receive oral hygiene instruction and professional prophylaxis prior to clinical examinations.
Key inclusion criteria (4 listed)
- Systemically healthy individuals
- over 18 years of age
- Subjects that received regenerative surgical treatment by customized 3D printed blocks.
- Subjects must agree to participate in the study and agree to sign the Informed Consent.
Key exclusion criteria (3 listed)
- Subjects with ilness that avoid their presence to the clinical evaluation
- ISubjects who have lost the customized blocks
- Subjects who do not agree to participate in the study will be excluded.
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 |
|---|---|---|
| Clinical evaluationClinical parmeters and radiographical analysis | Other | – |
Primary outcome
Periodontal Clinical Parameter of the implants Placed in the Grafted area
Time frame: 5 years
Marginal Bone Loss < 2mm
1 secondary outcome
Bone Graft Volume Alteration
Time frame: 6 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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontal Bone Loss, run by University of Guarulhos.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jamil A Shibli, DDS, PhD (+55 11 982593439, jshibli@ung.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Clinical Parameter of the implants Placed in the Grafted area (time frame: 5 years). 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 7 Jul 2026.