Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552065
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial
Detailed Description:
Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreatedThe detrimental effect of periodontitis results in soft tissue and hard tissue loss Bone defects has often resulted from tumor resection congenital malformation trauma fractures surgery periodontitis or around implants in dentistry as well as from diseases such as osteoporosis or arthritisThese deficiencies have been overcome through various treatment modalitiesIt is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus In addition bone grafts and membranes have been used to regenerate the lost bone
Among the membranes autogenous connective tissue graft remains as gold standard Collagen is biocompatible natural polymer that has a good function to promote new tissue formation In the proposed study immediate implants with compromised bone support cross-linked bovine collagen membrane will be used It is a naturally occurring protein having excellent biocompatibility and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments Further it is resistant to tension controllable biodegradability is non cytotoxic low antigenicity and excellent anti-inflammatory characteristics It is naturally reabsorbed by microorganisms easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted leading to improved immunogenicity
Bovine collagen is selected to enhance the biological function of silk fibroin as composite membrane for enhancement of gingival thickness Thus considering all these characteristics silk fibroin is incorporated into collagen membrane for evaluation As there is no literature assessing this composite membrane the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken
Among the membranes autogenous connective tissue graft remains as gold standard Collagen is biocompatible natural polymer that has a good function to promote new tissue formation In the proposed study immediate implants with compromised bone support cross-linked bovine collagen membrane will be used It is a naturally occurring protein having excellent biocompatibility and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments Further it is resistant to tension controllable biodegradability is non cytotoxic low antigenicity and excellent anti-inflammatory characteristics It is naturally reabsorbed by microorganisms easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted leading to improved immunogenicity
Bovine collagen is selected to enhance the biological function of silk fibroin as composite membrane for enhancement of gingival thickness Thus considering all these characteristics silk fibroin is incorporated into collagen membrane for evaluation As there is no literature assessing this composite membrane the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None