Clinical trial NCT06642753: Buccal Plate Augmentation Using Sticky Bone With Simultaneous Immediate Implant Placement
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immediate Implant
Keywords: buccal plate preservation
sticky bone
PRF
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: pink esthetic score
timeFrame: 3 and 6 months postoperative
Secondary outcomes:
measure: crestal bone level
timeFrame: baseline and 6 months post operative
measure: Thickness of labial plate of bone
timeFrame: baseline and 6 months postoperatively
measure: Soft tissue profile /contour
timeFrame: baseline, 3 and 6 months postoperatively.
measure: patient satisfaction
timeFrame: immediately after implant placement , 3 and 6 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
affiliation: Cairo University
name: Enji ahmed, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: shaimaa Nasr, Ass. Prof
role: STUDY_CHAIR
affiliation: Cairo University
name: Yara Kh Ghaith, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: samah bahaa, Lecturer
role: STUDY_CHAIR
References: