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Effect of Periodontal Therapy on Biomarkers in Periodontitis

2021年8月6日 更新者:Marmara University

Effect of Non-Surgical Periodontal Therapy on Salivary and Serum Biomarkers in Stage III Grade B and C Periodontitis

The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels in periodontitis stage III grade B (P-III-B) and C (P-III-C) patients. 20 periodontally healthy, 20 P-III-B and 25 P-III-C participants were enrolled. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received non-surgical periodontal treatment. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary MMP-8, MAF, MIP-1α, M-CSF, and IL34 levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

調査の概要

詳細な説明

Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. Macrophage-activating factor (MAF) can activate macrophages. M-CSF is known to modulate disease and inflammation and to play an important role in bone destruction. IL-34 shares vital functions of M-CSF, and manages myeloid cell survival, differentiation, and proliferation.

This study is the first controlled clinical study that examines the levels of MIP-1α, MAF, MMP-8, M-CSF, IL-34 in saliva and serum in two different periodontitis, and evaluates the situation before and after the treatment. The first hypothesis of this study; in periodontitis group, salivary and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will be high, in contrast to the periodontal healthy group. The second hypothesis of this study is that after periodontal treatment, saliva and serum MIP-1α, MAF, MMP-8, M-CSF, IL-34 levels will decrease. Based on these hypotheses, the aim of the study is; to compare the levels of MIP-1a, MAF, MMP-8, M-CSF, IL-34 in saliva and serum of healthy controls, P-III-B, and P-III-C subjects and to evaluate the effect of periodontal treatment.

A total of 65 systemically healthy patients; 20 periodontally healthy, 20 P-III-B, 25 P-III-C were included in this study. The whole mouth clinical periodontal examination included measurement of probing depth (PPD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI), and plaque index (PI) at 6 sites per tooth, except the third molars. The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant, which was supplemented with periapical radiographs if necessary.

Periodontal status of each patient was evaluated by a single calibrated periodontists with a manual probe. The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Periodontally healthy individuals (n=20) in the control group had no sites with PD >3 mm and CAL >2 mm and also no radiographic evidence of alveolar bone loss. BOP was <10% in the whole mouth. Healthy group also exhibited no history of periodontitis. The periodontitis stage III patients had a minimum three teeth apart from the first molars and incisors showing CAL ≥5 mm and PD ≥6 mm and showed no>4 teeth loss because of periodontitis. Radiographic bone loss extending from coronal to middle third or beyond. Radiographic bone loss was determined from the tooth showing the most severe bone loss as a percentage of root length. If the values of bone loss %/age were between 0.25 and 1.0, the patients were assigned to grade B (n=20). If higher than 1.0, the patients were assigned to grade C (n=25)

Treatment

The recruited periodontitis patients received conventional quadrant scaling and root planning (SRP) under local anesthesia in a total of 4 sessions in two weeks. SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes. Re-evaluations were performed at 1 and 3 months following the completion of the SRP. No periodontal intervention was carried out in the periodontally healthy controls.

Saliva and Serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 9:00 and 10:00 am. The participants were advised to avoid food consumption for three hours before sample collection. The participants were seated upright and saliva was collected over a period of 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker. Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80°C. A total of 5 mL of blood was collected from the antecubital fossa by venepuncture method. Serum was isolated from the blood by centrifuging at 5000 rpm for 10 minutes followed by its rapid transfer to a sterile polypropylene tube and storage at -80°C.

Biomarker Immunoassays Saliva and serum samples were thawed on ice. The saliva samples were centrifuged at 5.000 rpm for 15 minutes at room temperature, and supernatants were immediately used for assays. Serum and salivary samples of MMP-8 , M-CSF*, MIP-1α*, MAF , IL-34 in were measured by ELISA using commercial kits.

Statistical Analysis All statistical analyses were carried out with the standard statistical software package. For the intra-group comparisons, if the data were not normally disturbed, Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment. For inter-group comparisons, Mann-Whitney U test for normally and non-normally disturbed data. The Spearman's rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment. All tests were performed at significance level of P <0.05.

研究の種類

介入

入学 (実際)

65

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

      • Istanbul、七面鳥
        • Marmara University, Faculty of Dentistry, Department of Periodontology

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

23年~51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. systemically healthy and non-smoker individuals
  2. having ≥20 teeth present (except third molars)
  3. individuals with periodontally healthy, periodontitis stage III grade B and C diagnoses

Exclusion Criteria:

  1. having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
  2. usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
  3. having any non-inflammatory destructive periodontal disease
  4. nonsurgical/surgical periodontal therapy received in the past year
  5. pregnant/ lactating/ postmenopausal females.

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:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Periodontal healthy
アクティブコンパレータ:Periodontitis Stage III Grade B
The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks.
歯周炎患者の治療は手動および超音波器具を使用して行われました。
アクティブコンパレータ:Periodontitis Stage III Grade C
The patients were subjected to quadrant-wise full-mouth subgingival scaling and root planning under local anesthesia. The entire non-surgical periodontal treatment of periodontitis groups was completed in a total of 4 sessions in two weeks.
歯周炎患者の治療は手動および超音波器具を使用して行われました。

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
Salivary MMP-8 (ng/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in salivary MMP-8 levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary MAF (ng/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in salivary MAF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary MIP-1α (pg/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in salivary MIP-1α levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary M-CSF (pg/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Salivary IL-34 (pg/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in salivary M-CSF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment

二次結果の測定

結果測定
メジャーの説明
時間枠
血清IL-34 (pg/ml) レベル
時間枠:ベースラインから治療後1ヶ月および3ヶ月まで
ベースラインから治療後1か月および3か月までの血清IL-34レベルの変化
ベースラインから治療後1ヶ月および3ヶ月まで
Serum MMP-8 (ng/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in serum MMP-8 levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Serum MAF /ng/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in serum MAF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Serum MIP-1α (pg/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in serum MIP-1α levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment
Serum M-CSF (pg/ml) level
時間枠:baseline to 1 month and 3 months after treatment
change in serum M-CSF levels from baseline to 1 month and 3 months after treatment
baseline to 1 month and 3 months after treatment

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

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 (実際)

2019年1月23日

一次修了 (実際)

2020年7月24日

研究の完了 (実際)

2020年7月24日

試験登録日

最初に提出

2021年7月29日

QC基準を満たした最初の提出物

2021年8月6日

最初の投稿 (実際)

2021年8月16日

学習記録の更新

投稿された最後の更新 (実際)

2021年8月16日

QC基準を満たした最後の更新が送信されました

2021年8月6日

最終確認日

2021年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SAG-A-230119-0014

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