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NCT05442034 · ClinicalTrials.gov registry record · Phase 1
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
A Phase 1 study of Intrabony Periodontal Defect, sponsored by Nova Southeastern University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05442034: Recruiting Phase 1 study of Intrabony Periodontal Defect, sponsored by Nova Southeastern University.
NCT05442034 is a Phase 1 study of Intrabony Periodontal Defect that is actively recruiting participants, run by Nova Southeastern University. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05442034, a Phase 1 study of Intrabony Periodontal Defect, is actively recruiting participants, sponsored by Nova Southeastern University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Change in gingival recession and pocket probing depth
Conditions Studied
Interventions
- BIOLOGICAL growth factors to help in regeneration
Study Locations (1)
Florida
- Nova Southeastern University - Davie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
What NCT05442034 shows while recruiting
NCT05442034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
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.
NCT05442034 reports a single indexed study location in Florida.
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.
What interventions are being tested in trial NCT05442034?
The interventions under investigation include: growth factors to help in regeneration (BIOLOGICAL).
Who is sponsoring clinical trial NCT05442034?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05442034's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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