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Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane (MPM)

2013年5月21日 更新者:Ahmed Y Gamal、Al-Azhar University

Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Modified Perforated Membrane Barriers in Localized Intrabony Defects (An in Vivo Study)

One of the most important elements suggested to be provided through membrane perforations to augment regeneration are cell released growth factors from the overlying periosteal and gingival cells. A direct correlation could exist between the number of such cells and their available released growth factors. To test this assumption, this study was designed to evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during the early stages of healing for sites treated by MPM compared to that of the occlusive barrier membranes.

研究概览

地位

完全的

条件

详细说明

The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012. The criteria implemented for patient inclusion were: 1) no systemic diseases which could influence the outcome of the therapy; 2) good compliance with the plaque control instructions following initial therapy; 3) teeth involved were all vital with score 0 mobility ; 4) each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth 5) the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs; 6) selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy 7) endosseous radiographic defect angle ≤55 and ≥15 8) availability for the follow-up and maintenance program; 9) absence of periodontal treatment for the previous year; 10) absence of systemic medication or antibiotic treatment for the previous 6 months; 11) absence of a smoking habit and 12) absence of occlusal interferences. Pregnant females were excluded from participating in the study. Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule. The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012, clinical trial registration number: Al Azhar University 22-31). Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.

研究类型

观察性的

注册 (实际的)

15

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Cairo Governorate、埃及、1123
        • Al Azhar Universty

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

31年 至 51年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Fifteen non-smoking patients (8 males and 7 females) who were 31 to 51 years of age at the time of baseline examination (mean age 33.8 ± 6.1) with severe chronic periodontitis (Armitage 1999) participated in this prospective, randomized and blinded clinical trial. The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012. The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012). Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.

描述

Inclusion Criteria:

  1. no systemic diseases which could influence the outcome of the therapy;
  2. good compliance with the plaque control instructions following initial therapy;
  3. teeth involved were all vital with score 0 mobility ;
  4. each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth
  5. the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs;
  6. selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy
  7. endosseous radiographic defect angle ≤55 and ≥15
  8. availability for the follow-up and maintenance program;
  9. absence of periodontal treatment for the previous year;
  10. absence of systemic medication or antibiotic treatment for the previous 6 months;
  11. absence of a smoking habit and
  12. absence of occlusal interferences.

Exclusion Criteria:

  • Pregnant females were excluded from participating in the study.
  • Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
perforated membrane group
perforated membrane group (G1- 15 sites)
perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration
其他名称:
  • collagen membranes
occlusive membrane group
occlusive collagen membrane that are tradetionally used in guided tissue regeneration , control occlusive group (G2-15 sites)
tradetional occlusive collagen membrane
其他名称:
  • guided tissue membranes

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
gingival cervicular fluid BMP-2 level
大体时间:30 days
Using capillary tube (5 µl), gingival cervicular fluid (GCF) samples were collected (Sueda et al, 1969) by a single examiner (MA) who was masked to the attribution of the sites to MPM or OM. Following the isolation and drying of the selected site with cotton rolls, a fisher brand disposable micropipettes €, placed intrasulculary at the mesiofacial line angle of the selected site to a maximum depth of 2 mm below the gingival margin. Micropipettes were left in place until 5ul of fluid was collected. Gingival cervicular fluid (GCF) samples were collected one day, 3, 7, 14, 21, and 30 days after therapy and diluted in saline solution (50 µl) for bone morphogenetic protein-2 level evaluation. Samples were labeled, carried in a dark container and kept at -80 C until used.
30 days

次要结果测量

结果测量
措施说明
大体时间
intrabony components (defect bony filling)
大体时间:9 months
Clinical and radiographic measurements (pocket depth, attachement level, gingival index , plaque index, intrabony level) were reassessed at 3, 6, and 9 months after surgery.
9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ahmed Y Gamal, PhD、Al Azhar universty, faculty of dentistry, cairo, egypt
  • 研究主任:Mohamed M Aziz, BCH、al azhar universty, cairo, egypt
  • 研究主任:Mohamed M Helmy, MSD、Al Azhar Universty
  • 学习椅:Vencint J Iacono, PhD、Stony Brook Uiversty

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2013年5月19日

首先提交符合 QC 标准的

2013年5月21日

首次发布 (估计)

2013年5月22日

研究记录更新

最后更新发布 (估计)

2013年5月22日

上次提交的符合 QC 标准的更新

2013年5月21日

最后验证

2013年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ahmedgamal

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