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临床试验/NCT01860495
NCT01860495已完成不适用

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)

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
gingival cervicular fluid BMP-2 level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
31 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • no systemic diseases which could influence the outcome of the therapy;
  • good compliance with the plaque control instructions following initial therapy;
  • teeth involved were all vital with score 0 mobility ;
  • each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth
  • the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs;
  • 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
  • endosseous radiographic defect angle ≤55 and ≥15
  • availability for the follow-up and maintenance program;
  • absence of periodontal treatment for the previous year;
  • absence of systemic medication or antibiotic treatment for the previous 6 months;
  • absence of a smoking habit and
  • absence of occlusal interferences.

排除标准

  • 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.

结局指标

主要结局

gingival cervicular fluid BMP-2 level

时间窗: 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.

次要结局

  • intrabony components (defect bony filling)(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Y Gamal

professor of periodontology

Al-Azhar University

研究点 (1)

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