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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- pink esthetic score
研究概览
简要总结
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
详细描述
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- Venous blood will be withdrawn under aseptic conditions by veni puncture of the antecubital vein and transferred into sterile tubes which will be devoid of anticoagulants.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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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 .
干预措施: immediate implant with buccal plate augmentation using sticky bone (Biological)
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
干预措施: immediate implant with sticky bone as a filling material in the jumping gap (Biological)
结局指标
主要结局
pink esthetic score
时间窗: 3 and 6 months postoperative
This pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency .With the exception of papilla formation, the evaluation is performed visually by comparing reference teeth (i.e., with the contralateral tooth in the incisor zone and adjacent tooth in the premolar zone). For the mesial and distal papilla, the categories are complete, incomplete, and absent. For each criterion it is possible to award a score between two points (for a very good outcome) and no points (for a poor outcome). The maximum score that can be achieved is 14 points indicating an outcome that reflects complete conformity between the soft tissue of the tooth being assessed and that of the reference tooth.
次要结局
- crestal bone level(baseline and 6 months post operative)
- Thickness of labial plate of bone(baseline and 6 months postoperatively)
- Soft tissue profile /contour(baseline, 3 and 6 months postoperatively.)
- patient satisfaction(immediately after implant placement , 3 and 6 months postoperative)
研究者
Yara Khaled Mahmoud Khalefa Ghaith
Principal Investigator yara khaled Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University
Cairo University