Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390124
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-20
Brief Title:
Reconstructive Therapy of Peri-implantitis With PDGF-BB Gem-21
Sponsor:
Center of Implantology Oral and Maxillofacial Surgery Badajoz Spain
Organization:
Center of Implantology Oral and Maxillofacial Surgery Badajoz Spain
Study Overview
Official Title:
Reconstructive Therapy of Advanced Peri-implantitis-related Bone Defect With PDGF-BB Gem-21
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
Peri-implantitis is considered a bacteria-mediated inflammatory disease that leads to a progressive loss of support During the last decade research has been striving to understand this entity and strategies for primary and secondary prevention of the disease However all of them are about the effectiveness of different therapeutic modalities for their management In general it was stated that surgical therapy was ineffective in resolving inflammation Therefore surgical strategies are usually needed to eradicate the pathology
Taking advantage of the knowledge acquired during approximately a period of time about the surgical treatment of periodontitis if you propose several alternatives These are mainly based on the morphology of the defect although other factors such as the lack of keratinized mucosa or the habit of smoking can alter the decision-making process As such peri-implantitis with angular defects ie defects with infraosseous components is indicated for reconstructive measurements with no barrier membranes On the other hand horizontal defects ie defects with supra-crestal components are more likely to resolve by resecting therapy with or without bone contouring measures
It is interesting to note that although early data indicated that the morphology of the peri-implantitis defect often shows a well-contained circumferential defect it has recently been shown that it often presents a 23 wall defect configuration where the buccal plate is commonly missing bone wall The reason for this characteristic may recur in the dimension of the basal alveolar bones insufficient critical buccal bone thickness or implant positioning13 in relation to the bone envelope In addition it should be noted that 25 of peri-implantitis diagnosed on a daily basis exhibit a combined configuration of defects ie a combination of infraosseous and supra-critical components
For their reconstructive treatment many biomaterials have been documented among them several protocols proposed by our research group However the use of biological agents or growth factors has not been investigated for a long time Platelet Derived Growth Factor PDGF Platelet Derived Growth Factor is one of several Growth Factors or proteins that regulate cell growth and Cellular Division PDGF plays a significant role especially for Angiogenesis which implies the growth of blood vessels from the existing vascular tissue Uncontrolled angiogenesis is characteristic of cancer Chemically the PDGF is a Glucoprotein chains A -AA or B -BB or composed of them -AB In the field of periodontics periodontal regeneration has been shown to be successful in obtaining radiographic bone gain and tissue regeneration
Taking advantage of the knowledge acquired during approximately a period of time about the surgical treatment of periodontitis if you propose several alternatives These are mainly based on the morphology of the defect although other factors such as the lack of keratinized mucosa or the habit of smoking can alter the decision-making process As such peri-implantitis with angular defects ie defects with infraosseous components is indicated for reconstructive measurements with no barrier membranes On the other hand horizontal defects ie defects with supra-crestal components are more likely to resolve by resecting therapy with or without bone contouring measures
It is interesting to note that although early data indicated that the morphology of the peri-implantitis defect often shows a well-contained circumferential defect it has recently been shown that it often presents a 23 wall defect configuration where the buccal plate is commonly missing bone wall The reason for this characteristic may recur in the dimension of the basal alveolar bones insufficient critical buccal bone thickness or implant positioning13 in relation to the bone envelope In addition it should be noted that 25 of peri-implantitis diagnosed on a daily basis exhibit a combined configuration of defects ie a combination of infraosseous and supra-critical components
For their reconstructive treatment many biomaterials have been documented among them several protocols proposed by our research group However the use of biological agents or growth factors has not been investigated for a long time Platelet Derived Growth Factor PDGF Platelet Derived Growth Factor is one of several Growth Factors or proteins that regulate cell growth and Cellular Division PDGF plays a significant role especially for Angiogenesis which implies the growth of blood vessels from the existing vascular tissue Uncontrolled angiogenesis is characteristic of cancer Chemically the PDGF is a Glucoprotein chains A -AA or B -BB or composed of them -AB In the field of periodontics periodontal regeneration has been shown to be successful in obtaining radiographic bone gain and tissue regeneration
Detailed Description:
None
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