Impact of PTFE-d Barrier Intentionally Exposed in Guided Bone Regeneration to Ridge Preservation: Microbiological, Radiographic, Patient-centered Outcomes, Molecular Patter of Bone-related Markers and Implant Stabilization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- tomographic changes in bone height
研究概览
简要总结
The aim of this clinical-laboratorial, paralel, randomized, prospective and controlled study was determine the impact of of PTFE-d barrier intentionally exposed to bucal environment in guided bone regeneration to ridge preservation, using microbiological, radiographic, patient-centered outcomes, molecular patter of bone-related markers and implant stabilization. Fourty individuals with tooth extraction indication and subsequent implant placement between upper pre-molars were recruited. Patients were randomly allocated in one of this groups, following tooth extraction: 1) GBR: sockets received GBR with d-PTFE membranes which was maintained intentionally exposed to bucal environment and removed after 28 days; and 2) Non-GBR: sockets did not receive additional therapy after extration. After 3 months, all patients received dental implants and temporary implant-supported prostheses. Patient-reported outcomes in terms of morbidity, swelling and interference with daily life were recorded at 3, 7, 14, 28, 35 and 42 days following dental extraction and in terms of esthetic outcomes after prosthesis instalation by using questionaries. Samples of biofilm at surface repair/barrier were obtained in both groups at 3 and 28 days after extraction (in the moment of barrier removal) to microbiological evaluation using Illumina HiSeq system. Computed tomography obtained imediatlly after extraction and before implant placement will be analised to evaluation of changes on ridge dimensions. After 3 months following extration, bone tissue biopsies will be harvested from the sites designed to receive dental implants to evaluation of imunoenzimatic pattern (DKK1, OPG, OC, OPN, TNF-α, SOST, RANKL, OSN e TRAP) and gene expression (TGF-β, BSP e COL-I) of bone-related markers using Luminex/Magpix and PCR Real-Time, respectivally. Afer imlpant placement, the implant stability quotient (ISQ) was determined. The results will be statistically compared after normality test, with the level of significance set at 5%.
详细描述
Study design This clinical-laboratorial, paralel, randomized, prospective and controlled study will be determine the impact of of PTFE-d barrier intentionally exposed to bucal environment in guided bone regeneration to ridge preservation, using microbiological, radiographic, patient-centered outcomes, molecular patter of bone-related markers and implant stabilization.
Experimental groups
Following local anesthesia, an intrasulcular incision was made around the tooth to be extracted and a mucoperiosteal flap was detached for adequate exposure of 3 mm of the alveolar crest adjacent to the alveolus. After, procedures for dislocation and dental removal were performed in a minimally invasive manner, using periotomes, levers and extractors, if necessary. Subsequently, irrigation with saline solution was performed and then, using specific software, patients will be randomly assigned to receive one of the following treatments:
GBR Group: After extraction, the PTFE-d membrane (CytoplastTM Ti-250 Titanium-Reinforced, Anterior Narrow 12 mm x 24 mm, Osteogenics, Lubbock, TX, USA) was customized with scissors and adjusted over the socket, exceeding three millimeters from its margins. Then, the membrane was inserted subperiostally under the buccal and palatal flaps with the help of the Molt detacher. Minimal flap reflection was performed to stabilize the membrane, which was maintained intentionally exposed to the oral environment. Before suturing, the passive stability of the membrane over the alveolus was confirmed, as well as the absence of folds or wrinkles in the membrane. The flaps were then be approached in the pre-extraction position and sutured with crossed sutures, aiming to increase the stability of the membrane, with PTFE 4-0 thread (Cytoplast PTFE, CS0618PREM, Osteogenics, Lubbock, TX, USA).
Non-GBR group: After extraction, no further treatment was performed. The flaps were then repositioned and sutured with 5.0 nylon thread (Ethicon, Jonhson's Jonhson, São José dos Campos).
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged between 30 and 70 years old
- •with a tooth indicated for extraction and subsequent rehabilitation with dental implant
- •tooth extraction should be related to one of the teeth between maxillary premolars (premolar, canine, lateral or central incisor)
- •the reasons for extraction may include the impossibility of restorations due to the presence of extensive caries lesions, prosthetic failures, root fractures or endodontic failures.
- •the region to receive implants must present, radiographically, bone dimensions that allow the future placement of the dental implant and adequate prosthetic space for the subsequent prosthetic rehabilitation.
- •at least three bone walls must be present at the time of extraction.
排除标准
- •pregnancy
- •lactation
- •current smoking or ex-smokers
- •other systemic conditions that could affect bone metabolism (e.g., immunologic disorders)
- •use of anti-inflammatory, bisphosphonate and immunosuppressive medications.
结局指标
主要结局
tomographic changes in bone height
时间窗: baseline and at 3-month
tomographic changes in bone height
次要结局
- Microbioma analysys(3 days and 28 days)
- Probing Depth (PPD/mm)(baseline and at 3-month)
- Imunoenzimatic analysis of markers related to osteoclast / blastogenesis(3 months)
- Clinical attachament level(baseline and at 3-month)
- Gene expression analysis of markers related to osteoclast / blastogenesis(3 months)
- patient-centered parameters(3, 7, 14, 28, 35 and 42 days)
研究者
Fernanda Vieira Ribeiro
DDS, MS, PHD, Professor
Paulista University