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RECRUITING Phase 1

Rh-PDGF vs EMD for Treatment of Intra-bony Defects

NCT05442034 · View on ClinicalTrials.gov ↗

Study Summary

Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.

Interventions

  • BIOLOGICAL growth factors to help in regeneration

Study Locations (1)

Florida

  • Nova Southeastern University — Davie

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2023-01-01
Est. Completion 2025-06-30
Phase Phase 1

Sponsor

Nova Southeastern University

82 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05442034

The ClinicalTrials.gov registry entry for NCT05442034 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nova Southeastern University, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Intrabony Periodontal Defect appearing as the primary indexed condition, and to 1 intervention — of which growth factors to help in regeneration is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05442034 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05442034 about?

NCT05442034 is a clinical study titled "Rh-PDGF vs EMD for Treatment of Intra-bony Defects". Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease,...

What is the current status of trial NCT05442034?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-01-01. Estimated completion is 2025-06-30.

What conditions does trial NCT05442034 study?

This clinical trial studies the following conditions: Intrabony Periodontal Defect. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05442034?

The interventions under investigation include: growth factors to help in regeneration (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05442034?

This trial is sponsored by Nova Southeastern University, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05442034 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial