跳至主要内容
临床试验/NCT07162727
NCT07162727已完成不适用

"Efficacy of Non Perforated Titanium Foil Versus Collagen Membrane on Guided Bone Regeneration for Ridge Augmentation"

Dr R Viswa Chandra1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
bone height

研究概览

简要总结

Aim & Objectives: The aim of the present study was to clinically and radiographically evaluate the efficacy of titanium foil and collagen membrane in ridge augmentation.

Patients and methods: 18 subjects participated in this study. One site in each subjects was randomly assigned into each of the following experimental groups; Test group: ridge augmentation with titanium foil and control group: ridge augmentation with collagen membrane. Radiographic parameters included bone height, bone width and bone density. Evaluations of these parameters were performed after 3 months and 6 months by using Dentium Rainbow software & [reg]. Clinical parameters included the evaluation of Early Healing Score (EHS) during post operative healing period at 1 week and 1 month.

详细描述

Dental extractions can result in the loss of alveolar bone, leading to a decrease in both bone height and width, which may limit space for implant placement, particularly when taking aesthetic and prosthetic aspects into account.1 Various techniques have been developed for augmenting alveolar ridges, includes Guided Tissue Regeneration (GTR), Guided Bone Regeneration (GBR), onlay grafting, Distraction osteogenesis, which utilizes osteoconductive (scaffold-providing), osteoinductive (stimulating bone-forming cells), and osteogenetic (bone-producing cell-containing) properties.2 GBR membrane plays a vital role as a selective barrier that regulates cellular repopulation at the defect site. It prevents the rapid migration of soft tissue cells such as fibroblasts and epithelial cells, which could otherwise hinder bone regeneration. By excluding these cells, the membrane preserves a protected space that supports the slower infiltration and activity of osteogenic cells responsible for bone formation. Positioned between soft and hard tissues, it ensures a favourable environment for targeted bone regeneration by permitting only bone-forming cells to populate the area.3 GBR membranes are mainly categorized based on their degradation characteristics into non-resorbable (N-RES) and resorbable (RES) varieties. N-RES membranes such as titanium meshes, titanium foil and PTFE membranes offer reliable and enduring results. RES membranes are made from either natural or synthetic polymers, including xenogeneic native collagen, polyglycolide and polylactide polymers.4,5 The collagen membrane is utilized in guided bone regeneration because it can stimulate adhesion, chemotaxis and its own degradation along with that of its progenitor.6 The collagen membrane aids in wound healing by stabilizing clots, maintaining wound stability and hemostasis. It also serves as a scaffold that improves primary wound coverage to attract fibroblasts through its chemotactic properties.7,8 Its main drawbacks are rapid degradation rate and lack of stiffness, which can lead to a collapse of the barrier over the bone defect and diminish the space essential for bone regeneration.9,10 To reduce the risk of bacterial colonization at the graft site, the use of non-permeable occlusive titanium barriers (OTB) has recently been proposed as a promising alternative in reconstructive implant surgeries. These titanium barriers are designed to provide a completely sealed environment that effectively isolates the bone graft from the surrounding soft tissue and oral cavity, thereby minimizing microbial contamination. In addition to their superior biocompatibility and structural rigidity, OTBs offer the advantage of enhanced space maintenance and mechanical stability, which are crucial for successful bone regeneration in complex defects.11 This study aims to evaluate the effectiveness of non perforated titanium foil in comparison to traditional collagen membranes in ridge augmentation procedures, assessing their respective abilities to facilitate predictable and successful bone regeneration.

MATERIALS AND METHODS TRIAL DESIGN The trial was designed as randomized controlled clinical trial, to clinically and radiographically evaluate the efficacy of titanium foil and collagen membrane in ridge augmentation.

PARTICIPANTS AND ELIGIBILITY CRITERIA Subjects for the study were selected from the outpatient section of the Department of Periodontology, Sri Venkata Sai Institute of Dental Sciences, Mahbubnagar, Telangana and were followed up for over six months period after the procedures. Approval from Institutional Ethics Committee (SVSIDS/PERIO/4/2022) was obtained and informed consent was taken from the patients.

SELECTION CRITERIA:

Inclusion criteria:

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Systemically healthy male and female patients of age >18 years with atropic areas.
  • •Class IV (knife edge form with adequate height but in adequate width of alveolar process) and V (flat ridge form with loss of alveolar process) of Cawood and Howell27 classification.

排除标准

  • •Medically compromised patients
  • •patients <18 years of age
  • •pregnant women
  • •bruxism patients
  • •heavy smokers
  • •patients who underwent chemotherapy, radiotherapy in the past 12 months.

研究组 & 干预措施

titanium foil in ridge augmentation

Experimental

Full thickness mucoperiosteal flap was elevated, to expose the alveolar ridge defect. HA graft was placed onto the external defect upon which preformed titanium foil (Ti-foil®, India) depending on the size and extent of defect was placed. Foil was stabilized with the help of stainless steel screws of diameter 1.5 cm and length varied depending on the depth of the defect. The flaps were approximated and sutured without tension. Periodontal dressing was given.

干预措施: titanium foil in ridge augmentation (Device)

collagen membrane in ridge augmentation

Active Comparator

Full thickness mucoperiosteal flap was elevated, to expose the alveolar ridge defect. HA graft was placed onto the external defect upon which preformed collagen membrane depending on the size and extent of defect was placed. The flaps were approximated and sutured without tension. Periodontal dressing was given.

干预措施: collagen membrane (Device)

结局指标

主要结局

bone height

时间窗: 6 months

BH was measured from the crest of the alveolar ridge to the superior border of the mandibular canal in the mandible or to the floor of the nasal cavity or maxillary sinus in the maxilla. These measurements were recorded in millimeters (mm) at the center of the edentulous region.

bone width

时间窗: 6 months

Bone width was measured in the buccolingual dimension at three standardized levels: 1 mm below the crest (crestal level), mid-height of the alveolar ridge, basal bone (near cortical base). These measurements were done perpendicular to the long axis of the alveolar ridge using the ruler tool in the software.

bone density

时间窗: 6 months

Bone density was assessed using CBCT grayscale values (GV) as a surrogate for bone mineral density. Although it is not equivalent to Hounsfield Units (HU), relative GV were used for intra-study comparison. A 1 mm² region of interest (ROI) was selected at each measurement level (crestal, middle, and basal). GV values were recorded and averaged for statistical analysis.

次要结局

  • early healing score(1 month)

研究者

发起方
Dr R Viswa Chandra
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr R Viswa Chandra

Professor and head of the department

SVS Institute of Dental Sciences

研究点 (1)

Loading locations...

相似试验