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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Nasr City
      • Cairo、Nasr City、エジプト、1123
        • Ain Shams Universty

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

26年~49年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:collagen membranes
collagen barrier that help in isolating unwanted tissues in periodontal regneration
bovine collagen membrane used for selective tissue regeneration
他の名前:
  • guided tissue membranes
  • guided bone regeneration
  • occlusive membranes
collagen bovine occlusive membrane for selective tissue regneration
他の名前:
  • guided tissue membranes
  • guided bone regeneration
  • resorbable membranes

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
clinical corelation with the growth factors levels
時間枠:30 days
could this controled level of the growth factors acheived with perforated membrane has a clinical impact
30 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Ahmed Y Gamal, PhD、Ain Shams Universty

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年10月1日

一次修了 (実際)

2014年1月1日

研究の完了 (実際)

2014年3月1日

試験登録日

最初に提出

2014年6月7日

QC基準を満たした最初の提出物

2014年6月17日

最初の投稿 (見積もり)

2014年6月20日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年5月7日

QC基準を満たした最後の更新が送信されました

2015年5月6日

最終確認日

2015年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Al Azhar universty

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

collagen membraneの臨床試験

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