Histological Outcome of the Use of Different Biomaterials for Fresh Socket. A Split Mouth Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- type of bone maturation
研究概览
简要总结
Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points.
Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement, biopsies will be taken at different time points divided into three assessment groups: short duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months). The histologic findings will be assessed to quantify the trabeculae pattern, the degree of mineralization and the quality of bone regeneration.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in need of at least one bilateral tooth extraction due to one or more of the following causes:
- •periodontal disease,
- •vertical fracture
- •included teeth.
- •Patients seeking dental implant to replace their missing teeth.
- •All sockets should have intact or partially conserved buccal wall according to Elian´s classification (Type I, II).
排除标准
- •Patients under 18 years old.
- •Patients with a severely untreated periodontal disease.
- •Smokers of more than 15 cigarettes a day.
- •patients suffering from any systemic disease requiring pharmacological treatment.
- •Patients whose socket´s buccal wall is totally missing after tooth extraction
结局指标
主要结局
type of bone maturation
时间窗: 2-12 months
Histological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls
Degree of mineralization
时间窗: 2-12 months
Histological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls
次要结局
未报告次要终点
研究者
JAVIER MONTERO
Professor in Prosthodontics
University of Salamanca