此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Perforated Barrier Membranes Maintain Physiologic Gingival Crevicular Fluid Growth Factor Levels

2015年5月6日 更新者:Ahmed Y Gamal、Al-Azhar University

Perforated Barrier Membranes Maintain Physiologic Gingival Crevicular Fluid Growth Factor Levels During Treatment of Intrabony Defects: An In Vivo Proof-of-Principle Study

Membrane modifecation:

Guided tissue membrane perforations may serve as a more biologic scaffold that could allow for the free passage of biologic mediators from the periosteum and overlying gingival connective tissue into the periodontal defects.

Study hyposethis:

To test this hyposthesis, this study was designed to evaluate levels of vascular endothelial cell growth factors and platlet derived growth factors in gingival crevicular fluid (GCF) during the early stages of healing for localized intrabony defects treated with modified perforated membranes (MPMs), occlusive membranes (OMs) as compared to open flap debridement control (OFD).

Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this prospective, randomized and single blinded trial. Each patient contributed one interproximal defect that was randomly assigned to experimental modified perforated membrane group (10 sites), occlusive membrane group (10 sites) or open flap debridement control (10 sites). Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the intrabony depth of the defect (IBD) were measured at baseline for patients enrollment. Gingival crevicular fluid (GCF) samples were collected on day 1 and 3, 7, 14, 21, and 30 days after therapy. The primary outcome variable was the change in VEGF and PDGF-BB levels for sites treated by MPMs or OM compared to that of the OFD treated cases.

研究概览

详细说明

surgical procedures:

  • All surgeries were performed by the same operator (AYG).
  • The surgical treatment phase was initiated only if the subject had a full-mouth dental plaque score of less than one and site plaque score of 0.
  • Surgical procedures were accomplished as described in detail by Gamal and Iacono. 14 Under local anesthesia, a mucoperiosteal flap was elevated starting with an internal bevel incisions to the mucogingival junction to allow passive closure. Debridement of all inflammatory granulation tissue from the intrabony defect was performed by means of Gracey 7/8 metal curettes until a sound, healthy bone surface was obtained. At this time point, teeth were thoroughly root planed combining the use of metal curettes and power-driven instrumentation.
  • For MPM treated sites, collagen membrane perforations were prepared just before surgery using a custom made 1 mm diameter pin and 1mm perforated acrylic template with a coronal occlusive rim of about 3 mm . Inter-perforation spaces were determined to be not less than 2mm in order to avoid loss of membrane stiffness. Thereafter, collagen membranes were hydrated in sterile saline, trimmed according to the template prepared for each defect, and adapted over the defects in such a manner that the entire defect and ≥2 of the surrounding alveolar bone was completely covered to avoid membrane collapse within the defect. The membranes were extended supracrestally 1 mm below the CEJ to ensure optimum gingival CT involvement in supracrestal wound healing. Collagen membranes were simply adapted in place according to the surgical protocol of the manufacturer without suturing. The mucoperiosteal flap was coronally positioned covering the entire membrane and sutured with 5-0 non-resorbable suture .
  • No periodontal dressing was applied. OM and OFD sites were treated the same way except for using occlusive membranes or defect closure without using membranes. All patients received oral and written postoperative instructions.
  • Patients were prescribed amoxicillin (500 mg)‡ every 8 hours for 1 week. Subjects with allergies to amoxicillin and derivatives were prescribed Clindamycin (300 mg) every 8 hours.
  • Plaque control effort was supplemented by rinsing with chlorhexidine (0.12% chlorhexidine hydrochloride §) for one minute three times daily for 2 weeks. The patients were instructed to refrain from tooth brushing and interdental cleaning was avoided at the surgical areas during this time.
  • Sutures were removed 14 days postoperatively and recall appointments for observation of any adverse tissue reaction and oral hygiene reinforcement were scheduled every second week during the first 2 months after surgery.
  • One month after surgery, all patients were instructed to resume their normal mechanical oral hygiene measures, which consisted of brushing using a soft toothbrush with a roll-technique and flossing. Supportive periodontal maintenance including oral hygiene reinforcement and supragingival scaling was performed during each recall appointment.

Gingival Crevicular Fluid (GCF) Sampling:

To avoid irritation, samples were obtained 1 day following surgery and after individuals had fasted overnight and between 8:00AM and 10:00AM.

  • Using micropipettes (5 ul), GCF samples were collected 21 by a single examiner (MA) who was masked to the attribution of the sites to groups.
  • Following the isolation and drying of the selected site with cotton rolls, a fisher brand disposable micropipettes € was placed intrasulcularly 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 5 µl of fluid was collected.
  • GCF samples were collected at day 1, 3, 7, 14, 21, and 30 days after therapy and diluted in saline solution (50 µl) for evaluation of VEGF and PDGF-BB levels. Samples were labeled, carried in a dark container and kept at -26 C until used.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

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

    • Nasr City
      • Cairo、Nasr City、埃及、1123
        • Ain Shams 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

26年 至 49年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

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 no mobility ;

4) each subject contributed a single 2 or 3-wall intrabony interproximal defects around premolar or molar teeth without furcation involvement; 5) selected 2- or 3-wall intrabony defects (IBC) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of≥ 3 mm 6) selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 5 mm at the site of intraosseous defects four weeks following initial cause-related therapy; 6) availability for the follow-up and maintenance program; 7) absence of periodontal treatment during the previous year; 8) absence of systemic medications that could affect healing or antibiotic treatment during the previous 6 months; and 9) absence of occlusal interferences, open interproximal contacts (diastema, flaring or both).

Exclusion Criteria:

  • Pregnant females were excluded from participating in the study

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

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:collagen membranes
collagen barrier that help in isolating unwanted tissues in periodontal regneration
bovine collagen membrane used for selective tissue regeneration
其他名称:
  • guided tissue membranes
  • guided bone regeneration
  • occlusive membranes
collagen bovine occlusive membrane for selective tissue regneration
其他名称:
  • guided tissue membranes
  • guided bone regeneration
  • resorbable 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
platelet derived growth factor and endothelial cell growth factor levels in the gigival cervicular fluid during Treatment of Intrabony Defects: An in Vivo Proof-of-Principle Study
大体时间:30 days
membrane perforations could provide more physiologic growth factors concentrations in the defect area for their optimal effects. To test this assumption in a more controlled manner with a standard growth factors levels of open flap debridement treated sites, the objective of this study was to evaluate levels of platelet derived growth factors - BB (PDGF-BB) and vascular endothelial cell growth factor (VCGF) in GCF during the early stages of healing for sites treated with MPM or OM as compared with those sites treated with control OFD.
30 days

次要结果测量

结果测量
措施说明
大体时间
clinical corelation with the growth factors levels
大体时间:30 days
could this controled level of the growth factors acheived with perforated membrane has a clinical impact
30 days

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、Ain Shams Universty

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

2013年10月1日

初级完成 (实际的)

2014年1月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2014年6月7日

首先提交符合 QC 标准的

2014年6月17日

首次发布 (估计)

2014年6月20日

研究记录更新

最后更新发布 (估计)

2015年5月7日

上次提交的符合 QC 标准的更新

2015年5月6日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • Al Azhar universty

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅