Growth Factors vs EMD for Periodontal Defects
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've been on medications affecting periodontal status in the past 6 months, like Phenytoin or Alendronate.
What data supports the effectiveness of this treatment for periodontal defects?
Research shows that recombinant human platelet-derived growth factor (rhPDGF-BB) is effective in promoting wound healing and bone regeneration in periodontal defects, with long-term stability observed in a 36-month study. Additionally, enamel matrix derivative (EMD) has been compared to other treatments and shown to be effective in treating periodontal defects.12345
Is the treatment with growth factors and EMD safe for humans?
How is the drug GEM-21 (rhPDGF-BB) different from other treatments for periodontal defects?
Research Team
Theofilos Koutouzis, DDS, MS
Principal Investigator
Nova Southeastern University
Eligibility Criteria
This trial is for adults over 18 who've had scaling and root planing for periodontal disease, with deep pockets next to bone defects in their teeth. They must be able to come back for a 6-month check-up and not have serious health issues or habits like heavy smoking that could affect the results.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either rh-PDGF or EMD in combination with bone allograft for the treatment of intra-bony defects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enamel matrix derivatives (EMD)
- Recombinant human platelet derived growth factor (GEM-21)
Recombinant human platelet derived growth factor (GEM-21) is already approved in United States, European Union for the following indications:
- Periodontal intra-bony defects
- Periodontal intra-bony defects
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Southeastern University
Lead Sponsor