Rh-PDGF vs EMD for Treatment of Intra-bony Defects
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| ClinicalTrials.gov Identifier: NCT05442034 |
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Recruitment Status :
Recruiting
First Posted : July 1, 2022
Last Update Posted : August 15, 2023
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | June 28, 2022 | ||||||||
| First Posted Date ICMJE | July 1, 2022 | ||||||||
| Last Update Posted Date | August 15, 2023 | ||||||||
| Actual Study Start Date ICMJE | January 1, 2023 | ||||||||
| Estimated Primary Completion Date | June 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Clinical Attachment Changes [ Time Frame: 6 months ] Change in gingival recession and pocket probing depth
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| Original Primary Outcome Measures ICMJE |
Clinical Attachment Gain [ Time Frame: 6 months ] reduction in gingival recession and probing depth
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Rh-PDGF vs EMD for Treatment of Intra-bony Defects | ||||||||
| Official Title ICMJE | Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Test group will receive rh-PDGF in combination with bone allograft Control group will receive EMD in combination with bone allograft. Masking: Single (Participant)Masking Description: Participants will not know which biologic agent (rh-PDGF or EMD) is being used. Primary Purpose: Treatment
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| Condition ICMJE | Intrabony Periodontal Defect | ||||||||
| Intervention ICMJE | Biological: growth factors to help in regeneration
regenerative therapy
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
36 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 30, 2025 | ||||||||
| Estimated Primary Completion Date | June 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT05442034 | ||||||||
| Other Study ID Numbers ICMJE | 2022-217-NSU | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Nova Southeastern University | ||||||||
| Original Responsible Party | Islam Elderbashy, Nova Southeastern University, B.D.S, M.Sc | ||||||||
| Current Study Sponsor ICMJE | Nova Southeastern University | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Nova Southeastern University | ||||||||
| Verification Date | July 2023 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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