Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443476
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Tenting Abutment Technique Versus ScrewTent-Pole Technique for Augmentation of Posterior Atrophic Mandible
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
A Comparative Study Between Tenting Abutment Technique Versus ScrewTent-Pole Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-06
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:
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened In addition to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible
The tent pole provides excellent mechanical properties stability fixation yet very poor features to preserve the integrity of the soft tissue
Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole
The tent pole provides excellent mechanical properties stability fixation yet very poor features to preserve the integrity of the soft tissue
Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole
Detailed Description:
Augmentation of insufficient bone volume can be brought about by different methods including particulate and block grafting materials guided Bone Regeneration with or without growth and differentiation factors ridge splitting expansion and distraction osteogenesis either alone or in combination These techniques may be used for horizontalvertical ridge augmentation
Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity
Guided bone regeneration GBR describes the use of membranes to regenerate bony defects A membrane for GBR needs to be biocompatible cell occlusive non-toxic moldable and possess space-maintaining properties including stability
e Explanation for choice of comparators conventional titanium mesh Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest
B Objectives
a Aim of the study
To evaluate the quantity of gained bone under tenting abutment compared to a tent pole
To evaluate amount of wound dehiscence postoperatively using tenting abutment technique compared to a tent pole
To optimize the anatomical situation in order to facilitate implant installation
7b Hypothesis
Bone is a dynamic and living tissue with the capacity to repair and regenerate in response to injury It is further possible to guide bone cells into an area that previously consisted of bony tissue to regenerate bone and increase the bone volume
Tenting abutment is suitable as a biomaterial for creating a space between the bone cortex and the periosteum to enhance new bone regeneration
Tenting abutment material will enhance the quantity and quality of newly formed bone
Tenting abutment will cause less soft tissue dehiscence and will dramatically decrease the percentage of the collapse of the space produced by the bone graft and minimizes resorption of the grafting material compared to the titanium mesh
7c Primary and secondary objectives
1 Primary objective
Evaluate bone gained height and width and the period of time of healing in the atrophic posterior mandible when using tenting abutment technique compared to tent pole
2 Secondary objectives
Evaluation of soft tissue dehiscence and resorption of the grafting material that might occur using tent pole compared to the tenting abutment
Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity
Guided bone regeneration GBR describes the use of membranes to regenerate bony defects A membrane for GBR needs to be biocompatible cell occlusive non-toxic moldable and possess space-maintaining properties including stability
e Explanation for choice of comparators conventional titanium mesh Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest
B Objectives
a Aim of the study
To evaluate the quantity of gained bone under tenting abutment compared to a tent pole
To evaluate amount of wound dehiscence postoperatively using tenting abutment technique compared to a tent pole
To optimize the anatomical situation in order to facilitate implant installation
7b Hypothesis
Bone is a dynamic and living tissue with the capacity to repair and regenerate in response to injury It is further possible to guide bone cells into an area that previously consisted of bony tissue to regenerate bone and increase the bone volume
Tenting abutment is suitable as a biomaterial for creating a space between the bone cortex and the periosteum to enhance new bone regeneration
Tenting abutment material will enhance the quantity and quality of newly formed bone
Tenting abutment will cause less soft tissue dehiscence and will dramatically decrease the percentage of the collapse of the space produced by the bone graft and minimizes resorption of the grafting material compared to the titanium mesh
7c Primary and secondary objectives
1 Primary objective
Evaluate bone gained height and width and the period of time of healing in the atrophic posterior mandible when using tenting abutment technique compared to tent pole
2 Secondary objectives
Evaluation of soft tissue dehiscence and resorption of the grafting material that might occur using tent pole compared to the tenting abutment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None