Actively Recruiting
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Led by Nova Southeastern University · Updated on 2026-04-16
36
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.
CONDITIONS
Official Title
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nova Southeastern University
Davie, Florida, United States, 33314
Actively Recruiting
Research Team
N
Neshatafarin Manouchehri, D.D.S
CONTACT
T
Theofilos Koutouzis, DDS, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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