Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642753
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Buccal Plate Augmentation Using Sticky Bone With Simultaneous Immediate Implant Placement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Buccal Plate Augmentation Using Sticky Bone Versus Usage of Sticky Bone as a Jumping Gap Filling Material With Simultaneous Immediate Implant Placement in the Maxillary Esthetic Zone A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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 aim of this study is to clinically assess pink esthetic score following Buccal Plate Augmentation using Sticky Bone versus usage of Sticky Bone as a jumping gap filling material with simultaneous immediate implant placement in the maxillary esthetic zone
Detailed Description:
All patients will undergo pre-operative clinical examination Patients data will be collected name gender and age medical and dental histories will be taken Also all patients will undergo standardized periapical radiograph to detect any pathosis and a pre-operative Cone beam computed tomography CBCT scans will be taken to evaluate the tooth root configuration and to confirm the presence of intact buccal wall Vital structures related to the tooth Vertical and horizontal dimensions of the alveolar bone and Bone density
Patient preparation for surgical procedure
After extra oral disinfection of the surgical site the patients will be asked to rinse their mouths with Chlorohexidine HCL 125 mouthwash Orovex mouthwash Macro group Egypt immediately preoperatively Local infiltration anesthesia Articaine 4 1100000 epinephrine Artinibsa 40mg01 mgMl epinephrine 1100000 Spain will be used for all procedures
Control group
The surgical procedure will be performed in sterile surgical field Under local anesthesia sharp dissection of the supracrestal fibers will be done with no15 c scalpel blade With the purpose of preserving the buccal and palatal bone walls periotomes elevators and maxillary root forceps will be used to facilitate atraumatic extraction
The socket will be well irrigated with saline and debrided with a bone curette An intact buccal bone plate should be found after extraction of the tooth
Bony sockets will be prepared through sequential drilling for the placement of the implant
Achieving primary stability after implant placement will be followed by placement of cover screw
Venous blood will be withdrawn under aseptic conditions by veni puncture of the antecubital vein and transferred into sterile tubes which will be devoid of anticoagulants I- PRF preparation will be done using the protocol developed by Mourãoet al
Plastic PET tubes to create Liquid-PRF while glass tubes will be used to obtain Solid-PRF
Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug
Blood will be centrifuged at a speed of 700 rpm for 3 minutes An orange- colored fluid will be formed as the upper layer in the test tubes ie I- PRF Approximately 1 ml of I-PRF will be collected in a syringe
Solid-PRF Liquid-PRF mixed DBBM Solid-PRF membranes will be cut into small PRF fragments sized between 1-2 mm and mixed thoroughly with 025 g of DBBM particles Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM
Following polymerization by 15-20 minutes sticky bone will be ready to be grafted
The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants Further it will be covered with PRF membrane
the healing abutment will be screwed into the implant body
Intervention group
A thin periosteal elevator will be used to reflect the soft tissue buccal to the bony buccal plate on the mid-facial aspect of the socket in a full-thickness manner following a corono-apical direction thereby creating a surgical pouch
The dissection will be advanced beyond the mucogingival line to approximately two-thirds the depth of the socket and the pouch will be expanded in the mesio-distal direction to stretch the soft tissues away from the underlying bony plate
Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues
the healing abutment will be screwed into the implant body
Patient preparation for surgical procedure
After extra oral disinfection of the surgical site the patients will be asked to rinse their mouths with Chlorohexidine HCL 125 mouthwash Orovex mouthwash Macro group Egypt immediately preoperatively Local infiltration anesthesia Articaine 4 1100000 epinephrine Artinibsa 40mg01 mgMl epinephrine 1100000 Spain will be used for all procedures
Control group
The surgical procedure will be performed in sterile surgical field Under local anesthesia sharp dissection of the supracrestal fibers will be done with no15 c scalpel blade With the purpose of preserving the buccal and palatal bone walls periotomes elevators and maxillary root forceps will be used to facilitate atraumatic extraction
The socket will be well irrigated with saline and debrided with a bone curette An intact buccal bone plate should be found after extraction of the tooth
Bony sockets will be prepared through sequential drilling for the placement of the implant
Achieving primary stability after implant placement will be followed by placement of cover screw
Venous blood will be withdrawn under aseptic conditions by veni puncture of the antecubital vein and transferred into sterile tubes which will be devoid of anticoagulants I- PRF preparation will be done using the protocol developed by Mourãoet al
Plastic PET tubes to create Liquid-PRF while glass tubes will be used to obtain Solid-PRF
Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug
Blood will be centrifuged at a speed of 700 rpm for 3 minutes An orange- colored fluid will be formed as the upper layer in the test tubes ie I- PRF Approximately 1 ml of I-PRF will be collected in a syringe
Solid-PRF Liquid-PRF mixed DBBM Solid-PRF membranes will be cut into small PRF fragments sized between 1-2 mm and mixed thoroughly with 025 g of DBBM particles Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM
Following polymerization by 15-20 minutes sticky bone will be ready to be grafted
The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants Further it will be covered with PRF membrane
the healing abutment will be screwed into the implant body
Intervention group
A thin periosteal elevator will be used to reflect the soft tissue buccal to the bony buccal plate on the mid-facial aspect of the socket in a full-thickness manner following a corono-apical direction thereby creating a surgical pouch
The dissection will be advanced beyond the mucogingival line to approximately two-thirds the depth of the socket and the pouch will be expanded in the mesio-distal direction to stretch the soft tissues away from the underlying bony plate
Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues
the healing abutment will be screwed into the implant body
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