Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gingival margin distance
研究概览
简要总结
: Immediate Implant Placement with different materials of customized healing abutment for guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized controlled clinical trial.
详细描述
This randomized clinical trial evaluates the effect of customized PEEK healing abutment versus composite healing abutment regarding Clinical evaluate
- Gingival margin height
- Gingival contour width
- Gingival volume in BL & MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria of participants:
- •Periodontally and systemic healthy patients
- •Patients aged > 18 years
- •Non- restored teeth for many reasons (i.e. endodontic failure, unworthy for treatment in deep caries/non-caries lesion and root fracture), locate in the posterior area in the maxillary or mandibular arch indicate for customized implant with no need for additional bone and soft tissue augmentation procedures.
- •An adequate vertical bone for immediate implant placement.
- •Implants will be positioned with adequate primary stability so that transmucosal healing can be accomplished.
- •No taken medications known to interfere healing or periodontal tissue health or bone metabolism.
- •No previous periodontal surgery at involved sites.
- •Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
排除标准
- •Patients with active periodontal diseases (bleeding on probing- probing depth > 4 mm) or those under orthodontic treatment.
- •Poor oral hygiene (full mouth plaque score > 25% and full mouth bleeding score > 25%)
- •Smoking habits (> 10 cigarettes/day)
- •Severe acute or chronic periodontitis
- •Severe bruxism habits
- •History of oral/IV bisphosphonates taking
- •Remote or recent radiation therapy in the oro-maxillo-facial area or recent chemotherapy.
- •Xerostomia
- •Pregnant and lactating mothers
- •Patients who have been received periodontal surgery in the study area during the last year.
- •Clinical or radiographic signs of periapical pathology contraindicating immediate implant placement.
- •Implants showing signs of peri-implant mucositis and peri-implantitis during the study period will be excluded from the following analyses.
研究组 & 干预措施
immediate implant placement with customized composite healing abutment
- extraction of the Posterior teeth will be done with minimally invasive technique using periotome.
- Then, the digital surgical guide will be placed, and will be checked the affinity of the reference window with other teeth accurately in the optimal position. The osteotomies will be prepared with a surgical-guided surgery kit through a digital surgical guide and drill direction will be ensured by radiographic taking. Implant fixture insertion will be performed through this digital surgical guide.
- All patients will receive a bone-level implant with varying diameter and length in each case. After implant placement, the operator will scan the surrounding gingiva with a scan body immediately for a post-extraction digital model.
- Then the spaces between the implant fixture and alveolar bone wall will be filled with locally harvested autogenous bone and xenograft grafting material (OsteoBiol Gen-Os, Sweden).
干预措施: immediate implant placement with customized PEEK healing abutment (Other)
immediate implant placement with customized PEEK healing abutment
- an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning.
- Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve.
- Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth.
- Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it.
- The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery.
干预措施: immediate implant placement with customized PEEK healing abutment (Other)
结局指标
主要结局
Gingival margin distance
时间窗: Day 0 - month 3
The gingival margin distance will be measured from the highest gingival margin point in the buccal, palatal/lingual, mesial, and distal sides to the longitudinal implant line parallelly with the platform plane (buccal margin distance; BD, palatal/lingual margin distance; LD, mesial margin distance; MD and distal margin distance; DD).
Gingival margin height
时间窗: Day 0 - month 3
Gingival margin height will be measured from the highest gingival margin point in the buccal, lingual, mesial, and distal sides perpendicular to the platform plane (buccal height; BH, palatal/lingual height; LH, mesial height; MH and distal height; DH).
Gingival contour width
时间窗: Day 0 - month 3
The contour width will be measured from the outer sur face on the buccal and lingual sides to the implant center on the platform plane (buccal width; BW and palatal/lingual width; LW).
Gingival volume in BL & MD aspects
时间窗: Day 0 - month 3
Gingival volume will be measured on the gingiva above the platform plane for total gingival volume and separated with a mid-mesiodistal plane through the implant center for buccal and lingual gingival volume (total buccolingual volume; BLV, buccal volume; BV and lingual volume; LV).
次要结局
- The Functional Implant Prosthodontics Score(Day 0 - month 3)