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History of Changes for Study: NCT05442034
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Latest version (submitted August 11, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 28, 2022 None (earliest Version on record)
2 July 1, 2022 Outcome Measures, Study Status and Sponsor/Collaborators
3 July 10, 2022 Sponsor/Collaborators and Study Status
4 September 6, 2022 Study Status
5 March 5, 2023 Recruitment Status, Study Status and Contacts/Locations
6 July 27, 2023 Contacts/Locations, Study Status and Sponsor/Collaborators
7 August 11, 2023 Sponsor/Collaborators and Study Status
Comparison Format:

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Study NCT05442034
Submitted Date:  June 28, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2022-217-NSU
Brief Title: Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Official Title: Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2022
Overall Status: Not yet recruiting
Study Start: July 15, 2022
Primary Completion: May 30, 2023 [Anticipated]
Study Completion: December 30, 2023 [Anticipated]
First Submitted: June 28, 2022
First Submitted that
Met QC Criteria:
June 28, 2022
First Posted: July 1, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
June 28, 2022
Last Update Posted: July 1, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nova Southeastern University
Responsible Party: Principal Investigator
Investigator: Islam Elderbashy
Official Title: B.D.S, M.Sc
Affiliation: Nova Southeastern University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
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.

Open or close this module Conditions
Conditions: Intrabony Periodontal Defect
Keywords: Periodontal regeneration
Inta-bony defects
Enamel matrix derivatives
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Test group will receive rh-PDGF in combination with bone allograft Control group will receive EMD in combination with bone allograft.
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Biological: growth factors to help in 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.
Biological: growth factors to help in regeneration
regenerative therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Clinical Attachment Gain
[ Time Frame: 6 months ]

reduction in gingival recession and probing depth
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Islam M Elderbashy, B.D.S, M.Sc
Telephone: 7346047471
Email: ie109@mynsu.nova.edu
Central Contact Backup: Theofilos Koutouzis, DDS, MS
Telephone: 954-262-1742
Email: tkoutouzis@nova.edu
Study Officials: Theofilos Koutouzis, DDS, MS
Study Director
Nova Southeastern University
Locations: United States, Florida
Nova Southeastern University
Davie, Florida, United States, 33314
Contact:Contact: Islam elderbashy, B.D.S., M.Sc 7346047471 ie109@mynsu.nova.edu
Contact:Contact: Cristina Garcia-Godoy, DDS, MPH, CCRP 954-262-7388 cgarciag@nova.edu
Nova Southeastern University
Davie, Florida, United States, 33314
Contact:Contact: Islam elderbashy 7346047471 ie109@mynsu.nova.edu
Contact:Contact: Cristina Garcia Godoy, DDS, MPH, CCRP 954-262-7388 cgarciag@nova.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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