NCT07405918

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

January 21, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

January 21, 2026

Last Update Submit

April 26, 2026

Conditions

Keywords

Personalized bone graft3D printed customized bone blockGuided Bone RegenerationPersonalized Medicine

Outcome Measures

Primary Outcomes (1)

  • Periodontal Clinical Parameter of the implants Placed in the Grafted area

    Marginal Bone Loss \< 2mm

    5 years

Secondary Outcomes (1)

  • Bone Graft Volume Alteration

    6 years

Interventions

Clinical parmeters and radiographical analysis

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal DiseasesAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Central Study Contacts

Jamil A Shibli, DDS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04