Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05442034
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2022-06-28
Brief Title:
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Sponsor:
Nova Southeastern University
Organization:
Nova Southeastern University
Study Overview
Official Title:
Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 04- 197mm 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 andor 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 22mm vs 12mm and 3 years 23mm vs 11mm P 005 Comparable results were found when A Sculean et al 2004 tested CAL gain when enamel matrix proteins EMD was used versus OFD having 13mm of CAL gain at 5 years when the latter was used versus 29mm when the former was used p0001 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 35mm and 22mm 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 26 14 mm C60 16 15 mm T6 30 17 mm T60 30 07 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 22 mm vs 17 mm respectively
Platelet derived growth factors PDGF is a human serum polypeptide growth factor it is a potent mitogen for cells of mesenchymal origin eg 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
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 andor 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 22mm vs 12mm and 3 years 23mm vs 11mm P 005 Comparable results were found when A Sculean et al 2004 tested CAL gain when enamel matrix proteins EMD was used versus OFD having 13mm of CAL gain at 5 years when the latter was used versus 29mm when the former was used p0001 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 35mm and 22mm 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 26 14 mm C60 16 15 mm T6 30 17 mm T60 30 07 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 22 mm vs 17 mm respectively
Platelet derived growth factors PDGF is a human serum polypeptide growth factor it is a potent mitogen for cells of mesenchymal origin eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None