Regeneration of Alveolar Tissue After Maxillary Sinus Floor AugmentationPhase 1NCT07845006
Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
A Phase 1 study testing AI algorithms generated a 3D multiphasic, graded lattice structure in people with Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
The periodontal ligament is vital for tooth support, and its loss, frequently resulting from periodontitis, trauma, or endodontic lesions, presents a significant clinical challenge; global cases of severe periodontitis increased by 91.54% from 1990 to 2021. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
- What is being tested?
- AI algorithms generated a 3D multiphasic, graded lattice structure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2025to 3 Sep 2028
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Normal Lab investigation
Who cannot join
- Bone diseases , Bleeding disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: AI- Powered Multiphasic 3D Printed Scaffold for Periodontal Defect Regeneration
The periodontal ligament is vital for tooth support, and its loss, frequently resulting from periodontitis, trauma, or endodontic lesions, presents a significant clinical challenge; global cases of severe periodontitis increased by 91.54% from 1990 to 2021. Conventional monophasic scaffolds offer a uniform environment, limiting their efficacy in regenerating complex, multi-tissue structures like the periodontium. This study introduces an AI-enhanced, 3D multi-phasic scaffold to precisely restore the periodontal apparatus and overcome the limitations of non-uniform tissue growth seen in some multiphasic designs. The methodology involved sequential steps: high-resolution CBCT and intraoral scans to capture defect geometry; precise defect mapping to define the Target Regeneration Volume; and AI Mesh mixer implementation to generate three distinct, seamlessly graded lattice zones. This AI-driven design ensures Optimal Biomechanics (Precision) by perfectly matching the scaffold's stiffness to native tissue, thereby eliminating stress-shielding.
Read the detailed description
Background: The global prevalence of severe periodontitis increased by 91.54% between 1990 and 2021, driven primarily by population growth and population ageing, and now affects more than one billion people worldwide . Left untreated, periodontitis progressively destroys the attachment apparatus and is a leading cause of tooth loss. Conventional regenerative therapies rely largely on monophasic scaffolds, which impose a single, uniform biological and structural environment and therefore struggle to reproduce the layered, multi-tissue architecture of the periodontium. Study Problem: The periodontium is a composite of three histologically and mechanically distinct tissues - alveolar bone, the periodontal ligament (PDL), and cementum - each of which requires a different stiffness, porosity, and biochemical microenvironment for optimal regeneration. Monophasic scaffolds cannot satisfy this requirement simultaneously, which frequently results in fibrous encapsulation, incomplete integration, or stress-shielding. Objectives: This thesis examines the design, fabrication rationale, and clinical evaluation of an Artificial-Intelligence (AI)-boosted three-dimensional (3D) multiphasic scaffold intended to achieve simultaneous, tailored regeneration of alveolar bone, PDL, and cementum through a graded lattice architecture matched to native tissue stiffness. Methodology: The target regeneration volume was defined using high-resolution Cone-Beam Computed Tomography (CBCT) and intraoral optical scanning, processed through AI-assisted defect-segmentation software. A tri-zonal multiphasic scaffold - an outer bone-directed zone, a middle PDL-directed zone, and an inner cementum-directed zone - was generated and produced by 3D 2 Smart Scaffolds, Stronger Smiles bioprinting using biocompatible polymer and bio-ceramic bio-inks, then surgically placed in patients with severe infrabony defects. Clinical and radiographic outcomes were assessed at 2, 6, and 12 months post-operatively.
- Being tested
- AI algorithms generated a 3D multiphasic, graded lattice structure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI algorithms generated a 3D multiphasic, graded lattice structureProcedure or surgery
Patients underwent minimally invasive surgical intervention. Following preoperative diagnosis of severe infrabony defects exhibiting mobility and loss of periodontal support, a minimally invasive flap was elevated, and the defect was thoroughly debrided and prepared. The custom-printed multiphasic scaffold was seated into the defect with precision to ensure stability, and complete primary flap closure was achieved [
| Study group | Role | What they receive |
|---|---|---|
| 1 patient | Experimental | Not described Receives: Procedure: AI algorithms generated a 3D multiphasic, graded lattice structure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
the measured distance from the edge of the gum (gingival margin) to the bottom of the gum pocket or sulcus.
Measured: 12 months
Bone quality , PDL formation
refers to the density and architectural composition of the jawbone, which determines its strength and ability to stabilize a dental implant
Measured: 2,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start25 Nov 2025
- Primary completion14 May 2026
- Study completion3 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Regeneration of Alveolar Tissue After Maxillary Sinus Floor AugmentationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study evaluates the clinical and radiographic outcomes of 3D-bioprinted multiphasic scaffolds placed in severe periodontal infrabony defects. As with any interventional study involving human periodontal surgery, the protocol would be expected to require prior institutional/ethics-committee approval, documented informed consent, and - for interventional evaluation of a novel medical device/biomaterial - registration on a public clinical-trials registry, consistent with the reporting standards applied in the comparable FGF-2 and GTR trials cited throughout this thesis \[28,36\].
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Ahmed Sakr, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845006
- Sponsor's protocol ID
- FWA00025573
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
Lee CH, Hajibandeh J, Suzuki T, Fan A, Shang P, Mao JJ. Three-dimensional printed multiphase scaffolds for regeneration of periodontium complex. Tissue Eng Part A. 2014 Apr;20(7-8):1342-51. doi: 10.1089/ten.TEA.2013.0386. Epub 2014 Feb 6.
PubMed 24295512Sowmya S, Mony U, Jayachandran P, Reshma S, Kumar RA, Arzate H, Nair SV, Jayakumar R. Tri-Layered Nanocomposite Hydrogel Scaffold for the Concurrent Regeneration of Cementum, Periodontal Ligament, and Alveolar Bone. Adv Healthc Mater. 2017 Apr;6(7). doi: 10.1002/adhm.201601251. Epub 2017 Jan 27.
PubMed 28128898
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI- Powered Multiphasic 3D Printed Scaffold for Periodontal Defect Regeneration
- ClinicalTrials.gov ID
- NCT07845006
- Acronym / sponsor ID
- FWA00025573
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 3 Sep 2028 (estimated)
- First posted
- 28 Sep 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.
The periodontal ligament is vital for tooth support, and its loss, frequently resulting from periodontitis, trauma, or endodontic lesions, presents a significant clinical challenge; global cases of severe periodontitis increased by 91.54% from 1990 to 2021. Conventional monophasic scaffolds offer a uniform environment, limiting their efficacy in regenerating complex, multi-tissue structures like the periodontium. This study introduces an AI-enhanced, 3D multi-phasic scaffold to precisely restore the periodontal apparatus and overcome the limitations of non-uniform tissue growth seen in some multiphasic designs. The methodology involved sequential steps: high-resolution CBCT and intraoral scans to capture defect geometry; precise defect mapping to define the Target Regeneration Volume; and AI Mesh mixer implementation to generate three distinct, seamlessly graded lattice zones. This AI-driven design ensures Optimal Biomechanics (Precision) by perfectly matching the scaffold's stiffness to native tissue, thereby eliminating stress-shielding.
Detailed description
Background: The global prevalence of severe periodontitis increased by 91.54% between 1990 and 2021, driven primarily by population growth and population ageing, and now affects more than one billion people worldwide . Left untreated, periodontitis progressively destroys the attachment apparatus and is a leading cause of tooth loss. Conventional regenerative therapies rely largely on monophasic scaffolds, which impose a single, uniform biological and structural environment and therefore struggle to reproduce the layered, multi-tissue architecture of the periodontium. Study Problem: The periodontium is a composite of three histologically and mechanically distinct tissues - alveolar bone, the periodontal ligament (PDL), and cementum - each of which requires a different stiffness, porosity, and biochemical microenvironment for optimal regeneration. Monophasic scaffolds cannot satisfy this requirement simultaneously, which frequently results in fibrous encapsulation, incomplete integration, or stress-shielding. Objectives: This thesis examines the design, fabrication rationale, and clinical evaluation of an Artificial-Intelligence (AI)-boosted three-dimensional (3D) multiphasic scaffold intended to achieve simultaneous, tailored regeneration of alveolar bone, PDL, and cementum through a graded lattice architecture matched to native tissue stiffness. Methodology: The target regeneration volume was defined using high-resolution Cone-Beam Computed Tomography (CBCT) and intraoral optical scanning, processed through AI-assisted defect-segmentation software. A tri-zonal multiphasic scaffold - an outer bone-directed zone, a middle PDL-directed zone, and an inner cementum-directed zone - was generated and produced by 3D 2 Smart Scaffolds, Stronger Smiles bioprinting using biocompatible polymer and bio-ceramic bio-inks, then surgically placed in patients with severe infrabony defects. Clinical and radiographic outcomes were assessed at 2, 6, and 12 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study evaluates the clinical and radiographic outcomes of 3D-bioprinted multiphasic scaffolds placed in severe periodontal infrabony defects. As with any interventional study involving human periodontal surgery, the protocol would be expected to require prior institutional/ethics-committee approval, documented informed consent, and - for interventional evaluation of a novel medical device/biomaterial - registration on a public clinical-trials registry, consistent with the reporting standards applied in the comparable FGF-2 and GTR trials cited throughout this thesis [28,36].
| Arm | Type | Receives |
|---|---|---|
| 1 patient | Experimental | Procedure: AI algorithms generated a 3D multiphasic, graded lattice structure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Normal Lab investigation
Key exclusion criteria (1 listed)
- Bone diseases , Bleeding disorders
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 |
|---|---|---|
| AI algorithms generated a 3D multiphasic, graded lattice structurePatients underwent minimally invasive surgical intervention. Following preoperative diagnosis of severe infrabony defects exhibiting mobility and loss of periodontal support, a minimally invasive flap was elevated, and the defect was thoroughly debrided and prepared. The custom-printed multiphasic scaffold was seated into the defect with precision to ensure stability, and complete primary flap closure was achieved [ | Procedure or surgery | 1 patient |
Primary outcome
Probing Depth
Time frame: 12 months
the measured distance from the edge of the gum (gingival margin) to the bottom of the gum pocket or sulcus.
Bone quality , PDL formation
Time frame: 2,6,12 month
refers to the density and architectural composition of the jawbone, which determines its strength and ability to stabilize a dental implant
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 28 Sep 2026.
- Results publication: PubMed 24295512Lee CH, Hajibandeh J, Suzuki T, Fan A, Shang P, Mao JJ. Three-dimensional printed multiphase scaffolds for regeneration of periodontium complex. Tissue Eng Part A. 2014 Apr;20(7-8):1342-51. doi: 10.1089/ten.TEA.2013.0386. Epub 2014 Feb 6.
- Results publication: PubMed 28128898Sowmya S, Mony U, Jayachandran P, Reshma S, Kumar RA, Arzate H, Nair SV, Jayakumar R. Tri-Layered Nanocomposite Hydrogel Scaffold for the Concurrent Regeneration of Cementum, Periodontal Ligament, and Alveolar Bone. Adv Healthc Mater. 2017 Apr;6(7). doi: 10.1002/adhm.201601251. Epub 2017 Jan 27.
- In Vitro Mechanical and Biological Properties of 3D Printed Polymer Composite and β-Tricalcium Phosphate Scaffold on Human Dental Pulp Stem Cells. MaterialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Not decided yet
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AI algorithms generated a 3D multiphasic, graded lattice structure in people with Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation, run by Misr University for Science and Technology at 1 site in Egypt.
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 1 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: enrolling by invitation, as of the sponsor's last update on 28 Sep 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Probing Depth (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07845006, which also lists 2 linked publications.
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 28 Sep 2026.