Buccal Plate Augmentation Using Sticky Bone With Simultaneous Immediate Implant Placement

NCT ID: NCT06642753

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-31

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: Patient's 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 1.25% mouthwash (Orovex mouthwash, Macro group, Egypt) immediately preoperatively. Local infiltration anesthesia [Articaine 4% 1:100,000 epinephrine] (Artinibsa 40mg/0.1 mg/Ml ˗ epinephrine 1:100000, 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 no.15 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• Venous blood will be withdrawn under aseptic conditions by veni puncture of the antecubital vein and transferred into sterile tubes which will be devoid of anticoagulants.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 i.e., 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 0.25 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 .

Conditions

Immediate Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

immediate implant with buccal plate augmentation using sticky bone

atraumatic extraction.

• The socket will be well irrigated with saline and debrided with a bone curette.
• placement of the implant.
• Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
• sticky bone will be ready to be grafted.
• 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 .

Group Type: EXPERIMENTAL

immediate implant with buccal plate augmentation using sticky bone

Intervention Type: BIOLOGICAL

• Venous blood will be withdrawn 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 i.e., 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 mixed thoroughly with 0.25 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 in the pouch .

immediate implant with sticky bone as a filling material in the jumping gap

• atraumatic extraction.
• The socket will be well irrigated with saline and debrided with a bone curette.
• placement of the implant.
• Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
• 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

Group Type: ACTIVE_COMPARATOR

immediate implant with sticky bone as a filling material in the jumping gap

Intervention Type: BIOLOGICAL

Venous blood will be withdrawn 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 i.e., 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 mixed thoroughly with 0.25 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 in the jumping gap.

Interventions

immediate implant with buccal plate augmentation using sticky bone

• Venous blood will be withdrawn 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 i.e., 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 mixed thoroughly with 0.25 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 in the pouch .

Intervention Type: BIOLOGICAL

immediate implant with sticky bone as a filling material in the jumping gap

Venous blood will be withdrawn 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 i.e., 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 mixed thoroughly with 0.25 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 in the jumping gap.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older.
• Presence of a non-restorable maxillary tooth in the esthetic zone including maxillary anteriors and premolars indicated for extraction.
• An intact buccal plate of bone after extraction.
• Full-mouth plaque and bleeding score not exceeding 20%.
• Patients showing motivation to comply with post-operative care instructions and follow- up appointments.

Exclusion Criteria

• Periapical infection involving the tooth to be extracted.
• Periodontal disease
• Systemic health conditions that contraindicate or affect healing of implant surgery (Diabetes Mellitus, Leukemia)
• Pregnant and nursing females.
• Smokers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yara Khaled Mahmoud Khalefa Ghaith

Principal Investigator yara khaled Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enji ahmed, professor

Role: STUDY_DIRECTOR

Cairo University

shaimaa Nasr, Ass. Prof

Role: STUDY_CHAIR

Cairo University

Yara Kh Ghaith, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

samah bahaa, Lecturer

Role: STUDY_CHAIR

Cairo University

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yara KH Ghaith

Role: CONTACT

yara.khalefa@dentistry.cu.edu.eg

01025718437

Enji ahmed, Professor

Role: CONTACT

Enji.Ahmed@dentistry.cu.edu.eg

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

PER.6-3-1

Identifier Type: -

Identifier Source: org_study_id