Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559605
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Evaluation of Bone Gain Using Customized 3D Zirconia Barrier Versus Titanium Mesh
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Bone Gain Using Customized 3D Printed Zirconia Barrier Versus Titanium Mesh in Combined Ridge Defects in The Aesthetic Zone A Randomized Clinical Trial
Status:
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:
Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone
Detailed Description:
After a tooth is extracted the alveolar process undergoes an inevitable dimensional change as part of the post extraction remodeling process The alveolar process is reduced both in the vertical and the horizontal dimension Therefore Bone augmentation procedures have been employed to address this issue A number of bone grafting materials and membranes have been used including resorbable and non-resorbable membranes It is well-established that non-resorbable membranes produce greater bone augmentation than resorbable ones in terms of their ability to generate new bone However their complications make them a less popular option in everyday clinical practice
Zirconia surfaces show prominent osteo-conductivity also it has low affinity to bacterial plaque small amounts of inflammatory infiltrate and good soft-tissue integration Therefore this study aims to introduce customized-3D zirconia barriers as a predictable alternative to titanium mesh with horizontal bone gain used as primary outcome
A randomized clinical trial designed to evaluate the amount of bone gained clinically and radiographically using customized 3D printed zirconia barrier compared to titanium mesh with 26 sites with combined ridge defect total sample size 13 sites per arm Once patient preparation is completed and the radiographs are acquired the patient will be assigned into an arm in the study to allow for barrier manufacturing
For the zirconia group from the pre-operative CBCT a 3D model of the alveolar jawbone will be created A 04-05 mm-thick barrier will then be designed It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter The barrier will be milled and sintered after milling and finishing the zirconia meshes will be cleaned dis-infected and sterilized At the time of the surgery and after administration of anesthesia the full thickness flap of the atrophic area will be elevated adjacent to the defect site Autogenous bone particulate will be harvested Autogenous bone will be harvested by using an auto-chip maker ACM bur autogenous bone chips that collected with ACM bur will be mixed with a xenograft at 5050 ratio A try-in of the barrier will be performed before grafting the area to verify whether its adaptation to the recipient site will be correct A part of the graft will be placed into the atrophic area and the other part of it was placed into the inner side of the barrier The barrier will be then placed and according to the clinical situation two or three fixation screws were tightened at 10 Ncm
The titanium mesh group an aluminum foil will be adapted to the defect site and used as a guide for trimming the titanium mesh and ensure its adequate fit The titanium mesh will be polished to prevent dehiscence or premature exposure It will then stabilize over the particulate graft by 2 mm titanium mini screws at the labial and palatal sides Releasing incisions of the flaps will be the next step in the procedure Then suturing was performed with single and horizontal mattress sutures
The patient will be instructed to take antibiotics antiseptic mouth rinse anti-inflammatory drugs and instructed to apply an ice pack to the treated area for the first 24 hours and to avoid any brushing or trauma to the surgical site for one week
After 6 months of a healing period a post-operative CBCT will be performed to assess the effectiveness of the GBR procedure and then Dental implants will be placed according to the bone dimensions The osteotomy will be initially done using a 4 mm-diameter trephine bur instead of the pilot drill to acquire a core biopsy Sequential drilling will then take place until the correct osteotomy size is created for the implant size
Zirconia surfaces show prominent osteo-conductivity also it has low affinity to bacterial plaque small amounts of inflammatory infiltrate and good soft-tissue integration Therefore this study aims to introduce customized-3D zirconia barriers as a predictable alternative to titanium mesh with horizontal bone gain used as primary outcome
A randomized clinical trial designed to evaluate the amount of bone gained clinically and radiographically using customized 3D printed zirconia barrier compared to titanium mesh with 26 sites with combined ridge defect total sample size 13 sites per arm Once patient preparation is completed and the radiographs are acquired the patient will be assigned into an arm in the study to allow for barrier manufacturing
For the zirconia group from the pre-operative CBCT a 3D model of the alveolar jawbone will be created A 04-05 mm-thick barrier will then be designed It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter The barrier will be milled and sintered after milling and finishing the zirconia meshes will be cleaned dis-infected and sterilized At the time of the surgery and after administration of anesthesia the full thickness flap of the atrophic area will be elevated adjacent to the defect site Autogenous bone particulate will be harvested Autogenous bone will be harvested by using an auto-chip maker ACM bur autogenous bone chips that collected with ACM bur will be mixed with a xenograft at 5050 ratio A try-in of the barrier will be performed before grafting the area to verify whether its adaptation to the recipient site will be correct A part of the graft will be placed into the atrophic area and the other part of it was placed into the inner side of the barrier The barrier will be then placed and according to the clinical situation two or three fixation screws were tightened at 10 Ncm
The titanium mesh group an aluminum foil will be adapted to the defect site and used as a guide for trimming the titanium mesh and ensure its adequate fit The titanium mesh will be polished to prevent dehiscence or premature exposure It will then stabilize over the particulate graft by 2 mm titanium mini screws at the labial and palatal sides Releasing incisions of the flaps will be the next step in the procedure Then suturing was performed with single and horizontal mattress sutures
The patient will be instructed to take antibiotics antiseptic mouth rinse anti-inflammatory drugs and instructed to apply an ice pack to the treated area for the first 24 hours and to avoid any brushing or trauma to the surgical site for one week
After 6 months of a healing period a post-operative CBCT will be performed to assess the effectiveness of the GBR procedure and then Dental implants will be placed according to the bone dimensions The osteotomy will be initially done using a 4 mm-diameter trephine bur instead of the pilot drill to acquire a core biopsy Sequential drilling will then take place until the correct osteotomy size is created for the implant size
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