The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Evaluation of Implant Torque Value (ITV)
研究概览
简要总结
The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels.
详细描述
The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Male or female adult (≥ 18 years old)
- •Patients willing to participate and to attend the planned follow-up visits
排除标准
- •Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
- •History of leukocyte dysfunction and deficiencies
- •History of neoplastic disease requiring the use of radiation or chemotherapy
- •History of renal failure
- •Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •History of uncontrolled endocrine disorders
- •Alcoholism or any drug abuse
- •History of immunodeficiency syndromes
- •Smoker of 10 cig per day, cigar equivalents or tobacco chewers
- •Conditions or circumstances which in the opinion of the investigator would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
- •Mucosa disease such as erosive lichen planus
- •Residual post-extraction site with intact bone walls
- •History of local irradiation therapy
- •Persistent intraoral infection
研究组 & 干预措施
Tooth extraction and bone regeneration
The present arm received tooth extraction and guided bone regeneration (performed with xenograft porcine material and collagen barrier membrane). After 4 months, a dental implant was inserted.
干预措施: Tooth extraction, guided bone regeneration and dental implant (Procedure)
结局指标
主要结局
Evaluation of Implant Torque Value (ITV)
时间窗: Time of implant insertion: 4 months after extraction
Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device.
Evaluation of new formed bone tissue
时间窗: Time of implant insertion: 4 months after extraction
Evaluation of new formed bone tissue performed by histomorphometric methods.
Expression of Osteocalcin
时间窗: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Evaluation of Implant Stability Quotient (ISQ)
时间窗: Time of implant insertion: 4 months after extraction
Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W\&H)
Dimensional alveolar bone changes
时间窗: From extraction to implant insertion (4 months)
Volumetrical changes of alveolar bone after tooth extraction measured by superimposition of two intraoral scans. The first was registered before the extraction of the tooth. The second was registered after 4 months (before inserting implant). The parameter used to measure the dimensional alveolar bone change is called "Integrated Distance" and it is expressed in mm3.
Expression of Collagen A1
时间窗: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of Runx-2
时间窗: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Evaluation of Total Calcified Tissue (TCT)
时间窗: Time of implant insertion: 4 months after extraction
Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods.
Expression of Osteopontin
时间窗: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
次要结局
未报告次要终点