Enhancement of Deficient Buccal/Labial Bone Using Bone Ring Technique and Tent Pole Technique With Simultaneous Immediate Implant Placement: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Implant Stability
研究概览
简要总结
Introduction: Replacing single rooted teeth with immediate implant is quit challenging in the anterior region where the buccal bone is usually deficient, moreover the bone loss increases with the extraction of tooth and the cutting of the blood supply from the periodontal ligament. With the normal bone loss around successful implant about 0.2 mm per year, its essential to start with enough buccal bone bulk to ensure long survival of the implant.
The main disadvantage of guided bone regeneration is the inability of the membrane to protect the graft from the forces exerted during suturing of the flap at the end of the procedure and the forces exerted by the patient's muscles during mastication, leading to displacement of the bone graft. Tent pole technique suggest the use of monocortical screws to support the membrane preventing displacement of the bone graft. Bone ring technique suggest surrounding the implant by ring of bone which is fixed in place by the implant itself.
Aim: The aim of the study is to evaluate the effect of Bone Ring technique, and Tent-Pole technique on buccal/Labial bone with immediate implant placement.
Methodology: Clinical study will be done in 24 cases of single rooted teeth with deficient buccal bone and require replacement with immediate implant. The 24 cases will be divided into three groups ,8 cases each. In group A, immediate implant will be placed with traditional guided bone regeneration, in which the buccal bone will be enhanced by autogenous bone chips obtained from the symphysis area and then covered by resorbable membrane. In group B, immediate implant will be placed with bone ring technique, in which autogenous bone ring obtained from the symphysis will be placed around the implant and fixed in place by the implant itself. In group C, immediate implant will be placed with tent pole technique, in which monocortical screws will be placed to support the membrane covering the autogenous bone chips obtained from the symphysis area. the implant stability will be measured immediate after implant placement and after six months from the surgery using osstel system. The buccal bone volume changes will be measured by cone beam ct.
详细描述
Tooth loss is still considered an epidemic condition affecting populations in different areas of the world. Immediate implant aroused as an instant solution for tooth loss with its major advantages over the conventional implant technique including preservation of bone, better soft tissue esthetic, easier placement of implant with proper position and less number of visits with less treatment time leading to less cost.
The main obstacle facing immediate implant is the insufficient buccal bone whereas the buccal bone especially in the anterior region is usually thin cortical bone with no cancellous bone support. Deprived from the blood supply supplied by the cancellous bone support, the thin buccal cancellous bone receives blood supply only from the periosteum and the periodontal ligament of the adjacent teeth which is cut during extraction leading to further decrease in blood supply and increased bone resorption. Moreover, most of the teeth which need replacing is either periodontally or apically inflamed leading to more loss of buccal bone.
Guided bone regeneration which is defined as the use of a barrier membrane to direct the growth of new bone, has been the main key to solve the insufficient buccal bone problem. However Guided bone regeneration delays the implant placement by a period of time more than 6 months which is required by the bone to build up. To decrease the time of treatment, new researches suggested applying guided bone regeneration at the same time of placing immediate implant reducing the surgical procedures to one stage procedure. Parhiz and Refoua, in 2017 placed 27 immediate implants in sockets with buccal bone defect with appling guided bone regeneration at the same procedure. The results after 6 months showed 96.3% success rate with no suppuration or thread exposure.
The main drawback of regular guided bone regeneration is the inability of the weak membrane to protect the underlaying bone graft from the forces exerted be the flap tension during the final suturing due to insufficient soft tissue or forces exerted by the patient muscles during chewing leading to bone graft displacement and failure of bone formation. (Zhenya Su et al., 2021) Tent Pole technique suggest the use of monocortical screws to support the membrane and allow enough space for the bone graft. The monocortical screws are placed extending from the bone for few millimeters required to be augmented into bone to prevent the displacement of the membrane towards the bone. In 2020, Shah et al. studied the effect tent pole technique on 10 cases of buccally defected alveolar bone ridge. The results showed that tent pole technique is an effective in augmenting vertical bone defects. (Shah et al., 2020).In 2020, Doan et al. also came to the same results concluding that tent pole technique can increase horizontal ridge dimension with minimum complications.
Bone ring technique suggest the placement of bone ring around the crestal part of the implant. A trephine bure used to prepare the recipient site just to the same size of the bone ring prepared from wither autogenous bone, allograft or xenograft. The bone ring is then placed on the prepared recipient site and the osteotomy for the implant is done through its middle hole, considering the bone ring as a guide. The implant is then placed to fix the bone ring to the site.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with physical status classified as ASA class I and class II having single rooted tooth with buccal bone defect extending less than 3 mm from the alveolar bone crest which requires replacement.
- •There is bone extending at least 3mm beyond the root apex.
排除标准
- •Patients with physical status classified as ASA class III, class IV or class V.
- •Buccal bone defect extending more than 5 mm from the alveolar bone crest.
- •Smoker patient.
- •Presence of acute or chronic infection.
研究组 & 干预措施
Guided bone regeneration
Traditional guided bone regeneration will be done in which a 3D guided osteotomy will be done and the implant will be inserted, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.
干预措施: Guided bone regeneration (Procedure)
bone ring technique
Bone ring technique will be applied in which a trephine bure will be inserted through a 3D guide to prepare the site to receive the bone ring. The osteotomy will be done through the bone ring and the implant will be inserted to fix the implant in place, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.
干预措施: bone ring technique (Procedure)
tent pole technique
tent pole technique will be applied in which two monocortical screws will then be inserted using 3D guide, mesial and distal to the implant and extending 3 mm outside the bone, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.
干预措施: Tent pole technique (Procedure)
结局指标
主要结局
Implant Stability
时间窗: Initial stability will be measured immediately after implant insertion before placement of cover screw and final stability will be measured after 6 months from the surgery
stability of the implant will be measured by using a smartpeg which will be placed over the implant and the stability of the implant will be measured using Osstel ISQ system\* in Implant Stability Quotient (ISQ) value in both buccolingual and mesodistal direction with the average between the two reading being recorded.
Bone density
时间窗: To compare the changes in bone density in each group, the bone density around each implant was measured in two main CBCTs, which are the immediate post-operative CBCT and the final CBC taken 6 months postoperatively.
The same section will be fixed on the immediate post-operative CBCT and the final CBCT by taking the implant as a reference. the reference lines in both the immediate post-operative the final CBCTs will be placed in the middle of the implant at both cross-section view and panoramic view fixing the same section. The idea of using virtual implant is to fix the area measured whereas the area drawn manually can't be fixed in both CBCTs. The virtual implant will be chosen with the same dimension and design of the used implant, placed over the real implant in both the immediate post-operative and the final CBCTs taken 6 months postoperatively. The virtual implant placed over the real implant will then be adjusted in both axial and cross-sectional views. Using the OnDemand3D CBCT analyzing system the density of 2mm thickness of bone around the implant will be measured and converted to Housefield unit.
Buccal bone height
时间窗: A) Initial change The buccal bone height in preoperative CBCT will be compared to that in the immediate postoperative CBCT B) Final change The buccal bone height in preoperative CBCT will be compared to that in 6 months postoperative CBCT
The same cut will be fixed in a cross-sectional view with zero thickness in three CBCTs representing preoperative, immediate postoperative and 6 months postoperative. The height of the buccal bone will be measured from the buccal bone crest to a fixed anatomical structure in the three CBCTs. These fixed anatomical structures include floor of the nasal cavity and maxillary sinus in the upper jaw and inferior alveolar nerve and lower border of the mandible in the lower jaw.
Buccal bone width
时间窗: A) Initial change The buccal bone width in preoperative CBCT will be compared to that in the immediate postoperative CBCT B) Final change The buccal bone width in preoperative CBCT will be compared to that in 6 months postoperative CBCT
The maximum thickness of buccal bone in the coronal third of implant will be measured in cross sectional views with zero thickness in the three CBCTs representing preoperative, immediate postoperative and 6 months postoperative.
Full ridge width
时间窗: A) Initial change The maximum ridge thickness in preoperative CBCT will be compared to that in the immediate postoperative CBCT B) Final change The maximum ridge thickness in preoperative CBCT will be compared to that in 6 months postoperative CBCT
The maximum full ridge thickness in the coronal third of implant will be measured in fixed cross-sectional views with zero thickness in the three CBCTs representing preoperative, immediate postoperative and 6 months postoperative.
次要结局
未报告次要终点