Clinical and Histological Assessment of a Bone Substitute Enriched With Bioactive Glass for Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- histological analysis
研究概览
简要总结
The goal of this case series study is to evaluate the clinical and histological outcomes of a protocol for managing hopeless teeth, focusing on alveolar preservation and subsequent dental implant placement. The study will also assess the long-term success of prosthetic reconstruction. The main questions it aims to answer are:
- How effective is the use of biomaterials for alveolar preservation in maintaining bone structure and quality?
- What are the histological characteristics of the alveolar bone after biomaterial application?
- How successful are dental implants and prosthetic reconstructions in restored sites over a 1-year follow-up period?
Participants will:
- Undergo extraction of hopeless teeth using an atraumatic protocol.
- Receive alveolar preservation treatment with biomaterials immediately after extraction.
- Provide a bone biopsy for histological processing before implant placement.
- Undergo dental implant placement and prosthetic reconstruction of the lost tooth.
- Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 80 years of age.
- •Requirement for single-rooted tooth extraction due to reasons such as caries, fractures, restorative issues, endodontic complications (e.g., root fracture, instrument fracture), orthodontic needs, or prosthetic considerations.
- •Presence of at least one neighboring tooth adjacent to the extraction site.
- •Maintaining adequate oral hygiene, indicated by bleeding on probing <20% and plaque index <20%.
- •Presence of at least 50% of the buccal bone plate.
- •Classification of patients as ASA I or II status according to the American Society of Anesthesiologists Classification.
排除标准
- •All smokers, including smoking alternatives.
- •Heavy drinker (> 60 g of alcohol per day as a mean).
- •Uncontrolled metabolic disorders e.g., diabetes mellitus, osteomalacia, thyroid disorder, severe renal or hepatic disorder.
- •Prolonged corticosteroid therapy.
- •Immunological impairment diseases.
- •History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
- •General contraindications for dental and/or surgical treatment (including patients who take anticoagulants or antiresorptives).
- •Disease or condition affecting bone metabolism.
- •Women of child-bearing age, not using a highly effective method of birth control.
- •Pregnancy or breast feeding.
- •Previous and concurrent medication affecting sinus healing in general (e.g., topical steroids, large doses of anti-inflammatory drugs).
- •Acute or chronic oral infection or uncontrolled periodontal disease.
- •Crestal bone defects at the implantation site, which require additional bone augmentation around the neck of the implant.
- •Allergy to collagen.
- •Participation in an investigational device or drug clinical trial within the last six month.
结局指标
主要结局
histological analysis
时间窗: Samples will be collected at 2 and 3 months after the surgical intervention
Histological sections will be stained with hematoxylin-eosin (HE) and Masson's trichrome. A semi-quantitative analysis will be performed by a pathologist (Blinded for the groups), adopting a histological score system (0 - absence, 1- mild; 2 - mild to moderate, 3 - moderate to intense, and 4 - intense). These scores will be determined based on the intensity of the following histological parameters: necrosis, inflammatory infiltrate, fibrosis, biomaterial remnants, new-formed bone trabeculae, and angiogenesis. A histomorphometric analysis will also be performed for the trabecular bone area, cellularity area, and microvessel density.
次要结局
未报告次要终点
研究者
Giuseppe Alexandre Romito
Chairman of Periodontics Division
University of Sao Paulo