Impact of Modified Periosteal Inhibition Technique on Alveolar Bone Stability in Immediate Implant Placement Procedures (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiographic evaluation of horizontal and vertical dimensional changes of the alveolar bone placement by using cone beam computed tomography (CBCT).
研究概览
简要总结
To clinically and radiographically assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement, on alveolar bone dimensional changes, in comparison to the conventional flapless immediate implant approach.
详细描述
To assess the impact of the modified periosteal inhibition (MPI) technique, applied during immediate post-extraction implant placement in comparison to the conventional flapless immediate implant approach on radiographically by assessing marginal bone level measurements and bucco-lingual alveolar width. Clinically, pain levels, wound healing index, primary, secondary implant stability measured by resonance frequency analysis (RFA), peri-implant probing depth, and pink esthetic score (PES) will be assessed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's age ranges between 20 and 50 years including both genders.
- •General good health (American Society of Anesthesiologists I-II).
- •Presence of one hopeless non-restorable tooth requiring extraction at the posterior region.
- •Adequate amount of palatal bone and basal bone (≥ 3 mm) to engage the immediately placed implants.
- •Adequate keratinized soft tissue.
- •Thick gingival phenotype (˃ 1.5 mm).
- •Thin buccal bone plate or presence of fenestration.
- •Favorable pattern of occlusion.
- •Patient who is able to understand and sign a written consent.
排除标准
- •Pregnancy or lactating females.
- •Untreated periodontitis.
- •Acute dentoalveolar infection.
- •Complete absence of buccal bone plate.
- •Osteometabolic disease.
- •Chemotherapy or radiation therapy history of the neck-head area within the past 12 months.
- •Heavy smokers (>20 cigarettes/per day) according to WHO.
研究组 & 干预措施
Flapless immediate implant placement with cortico-cancellous bone allograft in the gap distance
Participants receive immediately inserted implant via flapless approach with the grafting of cortico-cancellous bone allograft in the gap distance between dental implant and surrounding native alveolar bone followed by insertion of customized healing abutment.
干预措施: Immediate implant placement via flapless approach (Procedure)
Immediate implant placement with MPI technique using collagen sponge in gap distance
Participants receive immediately inserted implant in conjunction with modified periosteal inhibition technique (MPI) after flap reflection from the buccal side and fixation of a 0.5 mm-thick cortical lamina glued to the buccal cortex with cyanoacrylate material. Collagen sponge will be filled in the gap distance followed by insertion of customized healing abutment.
干预措施: Immediate implant placement in conjunction with modified periosteal inhibition technique using collagen sponge in the gap distance (Procedure)
Immediate implant with MPI technique using cortico-cancellous bone allograft in gap distance
Participants receive immediately inserted implant in conjunction with MPI technique as described in group 2, however, cortico-cancellous bone allograft will be placed in the gap distance instead of collagen sponge and followed by insertion of customized healing abutment.
干预措施: Immediate implant placement in conjunction with modified periosteal inhibition technique using cortico-cancellous bone allograft in the gap distance (Procedure)
结局指标
主要结局
Radiographic evaluation of horizontal and vertical dimensional changes of the alveolar bone placement by using cone beam computed tomography (CBCT).
时间窗: Baseline, 6 months, 12 months after the implant placement
1. Marginal Bone Level Measurements: It is the distance between a fixed reference point and the most apical point of connection between the implant surface and the bone. The reference point is the fixture-abutment interface. 2. Bucco-lingual Alveolar Width: Width measurements will be made on tomographic slices perpendicular to the longitudinal axis of the alveolar crest at 1, 3 and 6 mm from summit of the alveolar crest.
次要结局
- Esthetic Evaluation(At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively)
- Pain Index(first post-operative day, third day and after one week.)
- Wound Healing Index (WHI)(1 and 2 weeks after surgery)
- Implant Stability Measurements(The RFA measurements will be made immediately after implant installation, and 3 months after implant placement before the prosthetic phase.)
- Peri-implant Probing Depth (PPD)(Baseline, 6 months and 12 months post-operatively.)
- Esthetic Evaluation(At the time of prosthetic phase (3 months after implant placement), 6 months, and 12 months postoperatively)
研究者
Meran Farid Hamza Awad
Assistant lecturer
Mansoura University