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Background:
A new bi-layer nanostructured collagen matrix CM-10826 was developed to be used as a conductor for intra-oral soft tissue regeneration.
Aim/Hypothesis:
The aim of the present study is to verify ultra-structurally with optical microscopy (OM), scanning electron microscopy (SEM) and transmission electron microscopy (TEM) the in vivo behaviour on humans of CM when used for grafting oral soft tissue defects.
Material and Methods:
CM-10826 is classified as an implantable, resorbable medical device class II. Thirteen non-smoking healty volunteers (from 21 to 75 years) were selected. The reconstruction of keratinized peri-implant tissues was planned with the use of a split-thickness apically positioned flap covering the exposed connective tissue with CM on test side and leaving the area for secondary intention healing on control side (split mouth). Histological evaluation in vivo were performed. Biopsies were performed at different times of healing to follow the healing process ultra-structurally. Samples were prepared for OM, SEM and TEM.
Results:
During early healing (10-15gg) the control side presented altered trophic zones, inflammation and micro-circulation alterations. In the late healing phase a not well organized superficial epithelium and a fibrotic aspect of the lamina propria was evident. In the test side spaces delimited by the collagen fibers were filled by an inflammatory infiltrate during the early phase. CM is integrated potentially acting as a scaffold for soft tissue regeneration. The greater thickness of lamina propria is evident in the reticular layer. During the late phase, the positive influence of the membrane is evidenced by the normal organization of epithelium and the high-degree maturation of connective tissue.
Conclusions and clinical implications:
CM has histologically shown to integrate in connective tissue and epithelium (10 days) and it resorbs (20 days) fast, leaving a healthy newly regenerated oral mucosa. CM reduces inflammatory infiltrate and stimulate cells and neo-angiogenesis. CM functions in oral surgery as substitute for autologous grafts and to avoid secondary intention healing in soft tissue defects.
Background:
A new bi-layer nanostructured collagen matrix CM-10826 was developed to be used as a conductor for intra-oral soft tissue regeneration.
Aim/Hypothesis:
The aim of the present study is to verify ultra-structurally with optical microscopy (OM), scanning electron microscopy (SEM) and transmission electron microscopy (TEM) the in vivo behaviour on humans of CM when used for grafting oral soft tissue defects.
Material and Methods:
CM-10826 is classified as an implantable, resorbable medical device class II. Thirteen non-smoking healty volunteers (from 21 to 75 years) were selected. The reconstruction of keratinized peri-implant tissues was planned with the use of a split-thickness apically positioned flap covering the exposed connective tissue with CM on test side and leaving the area for secondary intention healing on control side (split mouth). Histological evaluation in vivo were performed. Biopsies were performed at different times of healing to follow the healing process ultra-structurally. Samples were prepared for OM, SEM and TEM.
Results:
During early healing (10-15gg) the control side presented altered trophic zones, inflammation and micro-circulation alterations. In the late healing phase a not well organized superficial epithelium and a fibrotic aspect of the lamina propria was evident. In the test side spaces delimited by the collagen fibers were filled by an inflammatory infiltrate during the early phase. CM is integrated potentially acting as a scaffold for soft tissue regeneration. The greater thickness of lamina propria is evident in the reticular layer. During the late phase, the positive influence of the membrane is evidenced by the normal organization of epithelium and the high-degree maturation of connective tissue.
Conclusions and clinical implications:
CM has histologically shown to integrate in connective tissue and epithelium (10 days) and it resorbs (20 days) fast, leaving a healthy newly regenerated oral mucosa. CM reduces inflammatory infiltrate and stimulate cells and neo-angiogenesis. CM functions in oral surgery as substitute for autologous grafts and to avoid secondary intention healing in soft tissue defects.
Background:
A new bi-layer nanostructured collagen matrix CM-10826 was developed to be used as a conductor for intra-oral soft tissue regeneration.
Aim/Hypothesis:
The aim of the present study is to verify ultra-structurally with optical microscopy (OM), scanning electron microscopy (SEM) and transmission electron microscopy (TEM) the in vivo behaviour on humans of CM when used for grafting oral soft tissue defects.
Material and Methods:
CM-10826 is classified as an implantable, resorbable medical device class II. Thirteen non-smoking healty volunteers (from 21 to 75 years) were selected. The reconstruction of keratinized peri-implant tissues was planned with the use of a split-thickness apically positioned flap covering the exposed connective tissue with CM on test side and leaving the area for secondary intention healing on control side (split mouth). Histological evaluation in vivo were performed. Biopsies were performed at different times of healing to follow the healing process ultra-structurally. Samples were prepared for OM, SEM and TEM.
Results:
During early healing (10-15gg) the control side presented altered trophic zones, inflammation and micro-circulation alterations. In the late healing phase a not well organized superficial epithelium and a fibrotic aspect of the lamina propria was evident. In the test side spaces delimited by the collagen fibers were filled by an inflammatory infiltrate during the early phase. CM is integrated potentially acting as a scaffold for soft tissue regeneration. The greater thickness of lamina propria is evident in the reticular layer. During the late phase, the positive influence of the membrane is evidenced by the normal organization of epithelium and the high-degree maturation of connective tissue.
Conclusions and clinical implications:
CM has histologically shown to integrate in connective tissue and epithelium (10 days) and it resorbs (20 days) fast, leaving a healthy newly regenerated oral mucosa. CM reduces inflammatory infiltrate and stimulate cells and neo-angiogenesis. CM functions in oral surgery as substitute for autologous grafts and to avoid secondary intention healing in soft tissue defects.
Background:
A new bi-layer nanostructured collagen matrix CM-10826 was developed to be used as a conductor for intra-oral soft tissue regeneration.
Aim/Hypothesis:
The aim of the present study is to verify ultra-structurally with optical microscopy (OM), scanning electron microscopy (SEM) and transmission electron microscopy (TEM) the in vivo behaviour on humans of CM when used for grafting oral soft tissue defects.
Material and Methods:
CM-10826 is classified as an implantable, resorbable medical device class II. Thirteen non-smoking healty volunteers (from 21 to 75 years) were selected. The reconstruction of keratinized peri-implant tissues was planned with the use of a split-thickness apically positioned flap covering the exposed connective tissue with CM on test side and leaving the area for secondary intention healing on control side (split mouth). Histological evaluation in vivo were performed. Biopsies were performed at different times of healing to follow the healing process ultra-structurally. Samples were prepared for OM, SEM and TEM.
Results:
During early healing (10-15gg) the control side presented altered trophic zones, inflammation and micro-circulation alterations. In the late healing phase a not well organized superficial epithelium and a fibrotic aspect of the lamina propria was evident. In the test side spaces delimited by the collagen fibers were filled by an inflammatory infiltrate during the early phase. CM is integrated potentially acting as a scaffold for soft tissue regeneration. The greater thickness of lamina propria is evident in the reticular layer. During the late phase, the positive influence of the membrane is evidenced by the normal organization of epithelium and the high-degree maturation of connective tissue.
Conclusions and clinical implications:
CM has histologically shown to integrate in connective tissue and epithelium (10 days) and it resorbs (20 days) fast, leaving a healthy newly regenerated oral mucosa. CM reduces inflammatory infiltrate and stimulate cells and neo-angiogenesis. CM functions in oral surgery as substitute for autologous grafts and to avoid secondary intention healing in soft tissue defects.