3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation

April 26, 2026 updated by: Jamil awad shibli, University of Guarulhos
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jamil A Shibli, DDS, PhD
  • Phone Number: +55 11 982593439
  • Email: jshibli@ung.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal Clinical Parameter of the implants Placed in the Grafted area
Time Frame: 5 years
Marginal Bone Loss < 2mm
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Graft Volume Alteration
Time Frame: 6 years
Tomographic Volumetric Measurement (mm3) of the 3D printed graft after a period ranged between 1 to 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guarulhos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guaruhos University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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