Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634043
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Coronally Advanced Tunnel Combined with Xenogenic Dermal Matrix and L-PRF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Coronally Advanced Tunnel Combined with Xenogenic Dermal Matrix and L-PRF for the Treatment of Cairoamp39s Type 1 and Type 2 Multiple Recessions a Randomized Comparative Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
CAFXADM
Brief Summary:
Gingival recession is the exposure of the root surface due to the gum margin moving away from the crown of the tooth Its common in adults and becomes more prevalent and severe with age About 50 of people aged 18-64 and up to 88 of those over 65 have at least one site with gingival recession The causes are multifactorial including factors like aggressive brushing thin gum tissue orthodontic treatments and more
A systematic review found that untreated gingival recessions tend to worsen over time with a significant increase in both the number of sites and the depth of the recession A new classification system for gingival recessions has been proposed categorizing them based on the detection of the cementoenamel junction CEJ and interproximal attachment loss
Surgical techniques aim to restore the gum margin to its original position with minimal probing depths and good aesthetic results The standard treatment involves a connective tissue graft from a donor site but newer methods using substitutes like collagen matrices and platelet concentrates have shown comparable results
Acellular Dermal Matrix ADM is a processed dermal tissue used as a substitute for connective tissue in root coverage and implant soft tissue corrections It has shown favorable results especially in reducing patient morbidity and thickening the gingival phenotype ADM can be combined with a coronally positioned flap or tunnel technique for effective root coverage
The use of platelet concentrates such as Leukocyte and Platelet-Rich Fibrin L-PRF has also become an important alternative These concentrates improve healing by providing growth factors and cytokines aiding in the development of microvascularization
The objective is to assess whether combining Acellular Dermal Matrix ADM with Leukocyte and Platelet-Rich Fibrin L-PRF yields better or comparable results to ADM alone in terms of complete root coverage percentage of root coverage PRC recession reduction RecRED gain of keratinized gingiva KGG height of the interdental papilla IDH and increased gingival thickness GT after 6 months
A systematic review found that untreated gingival recessions tend to worsen over time with a significant increase in both the number of sites and the depth of the recession A new classification system for gingival recessions has been proposed categorizing them based on the detection of the cementoenamel junction CEJ and interproximal attachment loss
Surgical techniques aim to restore the gum margin to its original position with minimal probing depths and good aesthetic results The standard treatment involves a connective tissue graft from a donor site but newer methods using substitutes like collagen matrices and platelet concentrates have shown comparable results
Acellular Dermal Matrix ADM is a processed dermal tissue used as a substitute for connective tissue in root coverage and implant soft tissue corrections It has shown favorable results especially in reducing patient morbidity and thickening the gingival phenotype ADM can be combined with a coronally positioned flap or tunnel technique for effective root coverage
The use of platelet concentrates such as Leukocyte and Platelet-Rich Fibrin L-PRF has also become an important alternative These concentrates improve healing by providing growth factors and cytokines aiding in the development of microvascularization
The objective is to assess whether combining Acellular Dermal Matrix ADM with Leukocyte and Platelet-Rich Fibrin L-PRF yields better or comparable results to ADM alone in terms of complete root coverage percentage of root coverage PRC recession reduction RecRED gain of keratinized gingiva KGG height of the interdental papilla IDH and increased gingival thickness GT after 6 months
Detailed Description:
None
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