- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442034
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Alveolar bone crest is considered normal when it is found at a distance of 0.4- 1.97mm from the cementoenamel junction (CEJ) of the tooth. Chronic inflammation resulting from periodontal disease (PD) may lead to change in this architecture and formation of osseous defects. The variation in the form of these defects may be influenced by the occlusal stresses that the tooth is subjected to or the original form of the alveolar process in a localized area.
While Glickman chose to classify the osseous defects into "Osseous craters, intra-bony defects, bulbous osseous contours, hemi-septa, inconsistent margins and ledges"; Pritchard classified them as "interproximal craters, inconsistent margins, hemi-septa, furca invasions, intra-bony defects and a combination of these defects". Identifying the type of defect is of utmost importance. Intra-bony defects found in the interproximal areas can be one-wall, two-walls, or three-walls defects, depending on how many walls are remaining. On the other hand, when the inter-radicular bone is lost, its commonly classified as grade I, grade II, or grade III furcation.
Successful regeneration of the intra-bony defects will be accompanied by clinical attachment gain, decreased pocket depth, radiographic bone height gain, and improved periodontal health, to reach this goal, several types of bone grafts, membranes, biologics and/or combinations, have been investigated for potential application and, they proved success over short- and long-term.
Flemming et al. 1998, tested the bone gain following open flap debridement (OFD) versus allogeneic bone graft. The group that received allogenic bone graft had higher bone gain compared to the OFD group at 6 months (2.2mm vs 1.2mm) and 3 years (2.3mm vs 1.1mm) (P <0.05). Comparable results were found when A. Sculean et al 2004, tested CAL gain when enamel matrix proteins (EMD) was used versus OFD; having 1.3mm of CAL gain at 5 years when the latter was used versus 2.9mm when the former was used (p<0.001). Eickholz et al. 2004, tested the use of bioabsorbable membrane for the treatment of intra-bony defects with guided tissue regeneration. Attachment height gain was stable at 12- and 60-months follow up (3.5mm and 2.2mm). In a case series, Kim et al. compared the clinical attachment gain in 12 pairs of intra-bony defects in 12 subjects. One side was randomly assigned to receive GTR with a bioabsorbable membrane (Polyglactin) (control), while the contralateral received non-resorbable membrane (e-PTFE) (test). Both groups yielded significant clinical attachment gain at 6 (C6 and T6) and 60 months (C60 and T60), (C6: 2.6 ± 1.4 mm; C60: 1.6 ± 1.5 mm; T6: 3.0 ± 1.7 mm; T60: 3.0 ± 0.7 mm).
Emdogain is a biologic material that consists of hydrophobic enamel matrix proteins extracted from developing embryogenic enamel of porcine origin. It was first tested on monkeys for ability to regenerate buccal dehiscence defects and resulted in complete regeneration of the defect. It was later used in conjunction with Modified Widman Flap (MWF) and compared to MWF with placebo, for the regeneration of intra-bony defects in human subjects. At 36 months, the EMD group yielded significantly higher bone gain (2.2 mm vs 1.7 mm), respectively.
Platelet derived growth factors (PDGF) is a human serum polypeptide growth factor, it is a potent mitogen for cells of mesenchymal origin (e.g., fibroblasts), it stimulates collagen synthesis, chemotaxis of fibroblasts and production of insulin-like growth factors (IGF). It has been tested both in vitro and in vivo, it has proved potential for promoting soft tissue wound repair, and when used in periodontal defects, it stimulated healing with new bone and cementum formation, and a deposition of a continuous layer of osteoblasts was noticed lining the newly formed bone.
Based on the above evidence, it is now clear that different techniques and biomaterials can be used for periodontal regeneration. It is the purpose of the current study, to investigate the effect of rh-PDGF (test) in its commercial form (GEM21) and enamel matrix derivatives in its commercial form (EMD) (control) in combination with allografts for the treatment of periodontal defects in one-wall and two-walls intra-bony defects in human subjects.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Arsalan Danesh, D.D.S
- Phone Number: 5612126377
- Email: ad2900@mynsu.nova.edu
Study Contact Backup
- Name: Theofilos Koutouzis, DDS, MS
- Phone Number: 954-262-1742
- Email: tkoutouzis@nova.edu
Study Locations
-
-
Florida
-
Davie, Florida, United States, 33314
- Recruiting
- Nova Southeastern University
-
Contact:
- Arsalan Danesh, DDS
- Phone Number: 561-212-6377
- Email: ad2900@mynsu.nova.edu
-
Contact:
- Cristina Garcia Godoy, DDS
- Phone Number: 954-262-7388
- Email: cgarciag@nova.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft
recombinant human platelet derived growth factor is a protein that is found in blood serum.
It helps to recruit stem cells into the area to aid in cell differentiation and proliferation.
When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration.
|
regenerative therapy
|
Active Comparator: Enamel matrix derivatives (EMD) in combination with bone allograft.
Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle.
It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface.
When combined with bone allograft, it results in regeneration of intrabony defects.
|
regenerative therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Attachment Changes
Time Frame: 6 months
|
Change in gingival recession and pocket probing depth
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Theofilos Koutouzis, DDS, MS, Nova Southeastern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-217-NSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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