Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis: A Randomized Controlled Clinical Trial
Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis patients.
Methods: A randomized controlled clinical trial was conducted on forty patients with stage II periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after. Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Alexandria、エジプト、21521
- department of periodontology. Faculty of dentistry. Alexandria University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- systemically healthy individuals of both sexes having moderate periodontitis (stage II), CAL 3-4mm, with an age ranging from 25 to 45 years old.
- patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months
Exclusion Criteria:
- history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade C category that has rapid rate of progression, and pregnant or lactating women
研究計画
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Group I (test)
included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.
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Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
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プラセボコンパレーター：Group II (control)
included twenty treated with SRP and intrapocket application of placebo gel.
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Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
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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 |
|---|---|---|
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Change in periodontal pocket depth
時間枠：baseline and after 12 weeks
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the distance between the gingival margin and depth of probing
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baseline and after 12 weeks
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Change in clinical attachment loss
時間枠：baseline and after 12 weeks
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the distance between the CEJ and depth of probing
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baseline and after 12 weeks
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Change in Matrix metalloproteinase-8 level
時間枠：baseline and after 12 weeks
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Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample
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baseline and after 12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Souzy K. Anwar, Ph.D、periodontology department. Faculty of dentistry. Alexandria university
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- 研究プロトコル
- インフォームド コンセント フォーム (ICF)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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