Comparing two treatments for intra-bony periodontal defects
Official title: Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
Run by Nova Southeastern University · NCT05442034 · Data updated 2026-11-12
This study is testing whether a new treatment using growth factors works better than a standard treatment for helping adults with deep gum pockets heal and regain healthy gum tissue.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Nova Southeastern University Academic / other |
| Locations | 1 site (Davie, Florida) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT05442034 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with specific intra-bony defects and a history of periodontal disease.
✕Probably not a fit
Patients with uncontrolled diabetes, heavy smokers, or those on certain medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of recombinant human platelet-derived growth factor (GEM-21) versus enamel matrix derivatives (EMD) in treating intra-bony periodontal defects. Patients aged 18 and older who have persistent deep probing depths after scaling and root planing will be randomly assigned to receive one of the two treatments combined with an allogenic bone graft. The study will follow participants for six months to assess clinical attachment gain, pocket depth reduction, and radiographic bone height improvement. The trial seeks to enhance understanding of periodontal regeneration techniques and their outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with intra-bony periodontal defects, enhancing their periodontal health.
How similar studies have gone: Previous studies have shown promising results with similar regenerative approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age is 18 years old and older * Absence of relevant medical conditions * Availability for 6-month follow-up * Subjects who recently have received scaling and root planing due to periodontal disease * Single-rooted and multi-rooted teeth in either the maxilla or the mandible. * Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm. * Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects) * Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<20% at surgery Exclusion Criteria: * Female patients who are pregnant or planning to be pregnant during the period of the study * Heavy smokers (\>10 cigarettes a day) * Subjects not willing to comply to the study protocol * Patients with uncontrolled diabetes (HbA1c \>7.5) * Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate) * Periapical lesion in the tested sites
Where it's running
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Nova Southeastern University
Davie, Florida, United States Recruiting
Study contacts
- Study coordinator: Neshatafarin Manouchehri, D.D.S
- Email: nm1859@mynsu.nova.edu
- Phone: 7342494806
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Closed Surgical Technique vs Modified Papilla Preservation Technique in treating interdental periodontal defects
This trial tests whether the closed surgical technique with i-PRF can improve healing for isolated interdental periodontal defects better than the modified papilla preservation technique with i-PRF in adults.
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Early Wound Healing and Outcomes of Regenerative Periodontal Surgery
This study looks to see if healing in the first 1–2 weeks after periodontal regenerative surgery can predict how well the treatment works at 12 months in people with advanced periodontitis.
-
Using injectable platelet-rich fibrin with bovine bone grafts to treat intrabony periodontal defects
This will try adding injectable platelet-rich fibrin (i-PRF) to bovine bone grafts to see if adults with stage III periodontitis and intrabony defects heal better than with grafts alone.
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MIST with PRF versus GBT (with or without PRF) for treating a single deep intrabony periodontal defect
This trial tests whether adding platelet-rich fibrin (PRF) to a minimally invasive surgical approach (MIST) or to guided biofilm therapy (GBT) improves healing of a single deep intrabony periodontal defect in adults.
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Biologic agents added to non-surgical periodontal therapy for intrabony defects
This study tests whether adding rhPDGF, L-PRF, or enamel matrix derivatives to minimally invasive non-surgical therapy helps restore deep bone defects in periodontitis patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.