Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508476
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
The Efficacy of Amnion Chorion Allograft in Management of Gingival Recession
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Amnion Chorion Allograft in Management of Type 1 Gingival Recession Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
the main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession The main questions it aims to answer are Is it effective in treating gingival recession and how it compares to connective tissue graft
Detailed Description:
Gingival recession GR is characterized by apical migration of soft tissue margin beyond the cemento-enamel junction CEJ or the platform of an implant
Gingival recession is a common daily finding in every practice As patients are more concerned with a pleasing smile root exposure is a growing concern Moreover discomfort and inability to perform oral hygiene result from exposed root hypersensitivity It affects the patients abilities to maintain adequate plaque control which eventually complicates the situation more It is advisable to augment tissues and increase keratinized tissue KT band to reduce discomfort and obtain an aesthetic smile
multiple treatment modalities are available for treating gingival recession such as Pedicle flaps coronally advanced flap CAF semilunar flap laterally sliding flap lSD and double papilla flap Free gingival graft FGG Subepithelial connective tissue graft SCTG Guided tissue regeneration Modified coronally advanced tunnel Vestibular incision subperiosteal tunnel access VISTA Pinhole technique PST
Size and number of recession defects KT band interproximal attachment level depth vestibule and frenum pull are among factors to determine which procedure is suitable for that type of recession
For single-type recession localized or isolated the use of CAF with SCTG is favorable for both root coverage and KT gain According to the American Academy of Periodontology regeneration workshop for Miller class 1 and 2 single-tooth recession defects SCTG procedures provide the best outcome Using CAF combined with SCTG is considered the gold standard treatment for localized recession defects SCTG improves root coverage KT gain and clinical attachment levels Using SCTG helps stabilize CAF increase root coverage predictability and increase soft tissue thickness CAF with SCTG is a predictable technique to increase root coverage decrease recession depth and increase KT width and thickness
However obtaining an SCTG has some drawbacks such as the need for a second surgical site to harvest graft increases treatment time and patient morbidity Bleeding and postoperative discomfort are common after graft harvesting Another issue is a limited amount of tissue is also a concern in multiple defect cases Patients willingness to retreat was affected by previous autogenous grafting
Recently the use of placental membranes is introduced as a suitable substitute for SCTG The human placenta is composed of two membranes inner amniotic and outer chorionic membranes These membranes secrete anti-inflammatory cytokines and growth factors such as platelet-derived growth factor AA PDGF-AA and vascular endothelial growth factor VEGF These membranes have anti-inflammatory angiogenic antifibrotic and antimicrobial effects Furthermore they have low immunogenicity and improve epithelization They have been widely used in medicine since the 1910s with increasing clinical applications from wound care and ophthalmology to plastic surgery
There is a growing interest in using placental allografts as a substitute for conventional membranes in oral surgical procedures They are used for root coverage as a substitute for SCTG as these membranes contain different types of collagen proteoglycans laminin and bioactive factors which help in binding gingival epithelial cells to the root surface They act as reservoirs of stem cells which promote cell differentiation stimulate healing and help in revascularization
So in this study it is proposed to evaluate Amnion Chorion membrane in the management of gingival recession type 1 in comparison to SCTG
Aim of the study The primary outcome is to evaluate the effectiveness of the Amnion Chorion membrane ACM in the management of gingival recession type 1 RT1
The secondary outcome is to compare between ACM and subepithelial connective tissue graft in the treatment of recession defect type 1 RT1
Gingival recession is a common daily finding in every practice As patients are more concerned with a pleasing smile root exposure is a growing concern Moreover discomfort and inability to perform oral hygiene result from exposed root hypersensitivity It affects the patients abilities to maintain adequate plaque control which eventually complicates the situation more It is advisable to augment tissues and increase keratinized tissue KT band to reduce discomfort and obtain an aesthetic smile
multiple treatment modalities are available for treating gingival recession such as Pedicle flaps coronally advanced flap CAF semilunar flap laterally sliding flap lSD and double papilla flap Free gingival graft FGG Subepithelial connective tissue graft SCTG Guided tissue regeneration Modified coronally advanced tunnel Vestibular incision subperiosteal tunnel access VISTA Pinhole technique PST
Size and number of recession defects KT band interproximal attachment level depth vestibule and frenum pull are among factors to determine which procedure is suitable for that type of recession
For single-type recession localized or isolated the use of CAF with SCTG is favorable for both root coverage and KT gain According to the American Academy of Periodontology regeneration workshop for Miller class 1 and 2 single-tooth recession defects SCTG procedures provide the best outcome Using CAF combined with SCTG is considered the gold standard treatment for localized recession defects SCTG improves root coverage KT gain and clinical attachment levels Using SCTG helps stabilize CAF increase root coverage predictability and increase soft tissue thickness CAF with SCTG is a predictable technique to increase root coverage decrease recession depth and increase KT width and thickness
However obtaining an SCTG has some drawbacks such as the need for a second surgical site to harvest graft increases treatment time and patient morbidity Bleeding and postoperative discomfort are common after graft harvesting Another issue is a limited amount of tissue is also a concern in multiple defect cases Patients willingness to retreat was affected by previous autogenous grafting
Recently the use of placental membranes is introduced as a suitable substitute for SCTG The human placenta is composed of two membranes inner amniotic and outer chorionic membranes These membranes secrete anti-inflammatory cytokines and growth factors such as platelet-derived growth factor AA PDGF-AA and vascular endothelial growth factor VEGF These membranes have anti-inflammatory angiogenic antifibrotic and antimicrobial effects Furthermore they have low immunogenicity and improve epithelization They have been widely used in medicine since the 1910s with increasing clinical applications from wound care and ophthalmology to plastic surgery
There is a growing interest in using placental allografts as a substitute for conventional membranes in oral surgical procedures They are used for root coverage as a substitute for SCTG as these membranes contain different types of collagen proteoglycans laminin and bioactive factors which help in binding gingival epithelial cells to the root surface They act as reservoirs of stem cells which promote cell differentiation stimulate healing and help in revascularization
So in this study it is proposed to evaluate Amnion Chorion membrane in the management of gingival recession type 1 in comparison to SCTG
Aim of the study The primary outcome is to evaluate the effectiveness of the Amnion Chorion membrane ACM in the management of gingival recession type 1 RT1
The secondary outcome is to compare between ACM and subepithelial connective tissue graft in the treatment of recession defect type 1 RT1
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