recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft for Periodontal Intrabony Defects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nova Southeastern University, Davie, FL
Periodontal Intrabony Defects
growth factors to help in regeneration - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 6 months

6 months
Clinical Attachment Changes
Clinical Attachment Gain

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Enamel matrix derivatives (EMD) in combination with bone allograft.
1 of 2
recombinant human platelet derived growth factor (rh-PDGF) in combination with b...
1 of 2
Active Control
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft · No Placebo Group · Phase 1 & 2

recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft
Biological
Experimental Group · 1 Intervention: growth factors to help in regeneration · Intervention Types: Biological
Enamel matrix derivatives (EMD) in combination with bone allograft.
Biological
ActiveComparator Group · 1 Intervention: growth factors to help in regeneration · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Trial Background

Islam Elderbashy, Student
Principal Investigator
Nova Southeastern University
Closest Location: Nova Southeastern University · Davie, FL
2006First Recorded Clinical Trial
1 TrialsResearching Periodontal Intrabony Defects
15 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years old.
Subjects who have received scaling and root planing due to periodontal disease.
You have one or more single-rooted or multi-rooted teeth in either the maxilla or the mandible.
You have a pocket of PD ≥ 6 mm with an associated interdental component of 3 to 6 mm.
You have at least one non-contained intra-bony defect.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.