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Evaluation of Gingival Tissue Protein Levels of Serum Amyloid A Family Members

2026年11月10日 更新者：Burcu KARADUMAN

The primary aim of this study is to determine the serum amyloid A (SAA) family protein levels in gingival tissue samples obtained from periodontally healthy and periodontitis patients and to evaluate their relationship with periodontal status. Additionally, the study aims to assess the potential effect of smoking on the amount of SAA proteins in gingival tissue.

Following ethical committee approval, a total of 108 individuals aged 18-65 years who attending to the Department of Periodontology, Biruni University Faculty of Dentistry, will be included in the study. The study groups will consist of 27 non-smoking individuals with periodontally healthy tissue, 27 smoking individuals with periodontally healthy tissue, 27 non-smoking individuals with stage III grade B periodontitis, and 27 smoking individuals with stage III grade C periodontitis. The non-smoking groups will include individuals who have never smoked, while the smoking groups will include individuals who, according to patient statements, have smoked at least 10 cigarettes per day for more than five years.

All participants will be informed about the study and their written consent will be obtained. Plaque score, probing depth, gingival margin position, clinical attachment level, and bleeding on probing will be measured by a calibrated investigator. Gingival tissue samples from periodontally healthy individuals will be collected during planned tooth extraction or periodontal surgical procedures such as gingivoplasty, gingivectomy, or clinical crown lengthening, independent of the study. Only gingival tissues that would otherwise be discarded as medical waste during routine treatment will be used. In individuals with periodontitis, granulation tissue removed during subgingival instrumentation as part of non-surgical periodontal treatment is planned for use. No additional tissue will be removed from the periodontal pocket wall or junctional epithelium for research purposes; the scope of the clinical procedure will not be expanded if suitable tissue cannot be obtained.

Gingival tissue samples will only be collected initially, stored at -80°C until the day of analysis, and evaluated using the ELISA method.

調査の概要

状態

まだ募集していません

条件

研究の種類

観察的

入学 (推定)

108

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。

研究連絡先

研究連絡先のバックアップ

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

18年～65年 (大人、高齢者)

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

サンプリング方法

非確率サンプル

調査対象母集団

Adults aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Biruni University, who meet the study eligibility criteria. A total of 108 participants will be included in four groups of 27: periodontally healthy never smokers, periodontally healthy smokers, never smokers with stage III grade B periodontitis, and smokers with stage III grade C periodontitis. Periodontally healthy participants must have an independent clinical indication for tooth extraction or periodontal surgery during which gingival tissue would otherwise be discarded.

説明

Inclusion Criteria:

  • Participants must meet the periodontal disease and health criteria,
  • Be between 18-65 years of age,
  • Periodontally healthy participants must have an indication for tooth extraction or surgical periodontal treatment where a gingival tissue sample can be collected as part of the treatment plan,
  • Not have a systemic disease that may affect the pathogenesis of periodontal disease,
  • Not be pregnant or breastfeeding,
  • Not be using any medication that may affect the immune system,
  • Not have used antibiotics or anti-inflammatory drugs in the last 3 months,
  • Not have received any periodontal treatment in the last 3 months.

Exclusion Criteria:

  • Having diseases that may affect periodontal tissues, the course of periodontal disease, and the response to periodontal treatment,
  • Using medications that may affect periodontal tissues, the course of periodontal disease, and the response to periodontal treatment,
  • Being pregnant or breastfeeding,
  • Chronic alcohol use,
  • Using antibiotics or anti-inflammatory drugs within the last 3 months,
  • Having received periodontal treatment within the last 3 months.

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

  • 観測モデル：CASE_CONTROL
  • 時間の展望：CROSS_SECTIONAL

コホートと介入

グループ/コホート
Periodontally Healthy Non-smokers

Twenty-seven adults aged 18-65 years who have never smoked, with periodontal health on an intact periodontium, probing depths ≤3 mm, bleeding on probing at <10% of sites, no radiographic bone loss, and no history of periodontal disease.
Periodontally Healthy Smokers

Twenty-seven adults aged 18-65 years who report smoking ≥10 cigarettes per day for more than 5 years, with periodontal health on an intact periodontium, probing depths ≤3 mm, bleeding on probing at <10% of sites, no radiographic bone loss, and no history of periodontal disease.
Stage III Grade B Periodontitis

Twenty-seven adults aged 18-65 years who have never smoked and have stage III grade B periodontitis. Clinical criteria include clinical attachment loss ≥5 mm at ≥2 nonadjacent teeth, radiographic bone loss extending to the middle third of the root or beyond, loss of ≤4 teeth due to periodontitis, probing depths ≥6 mm, vertical bone loss ≥3 mm, and ≥20 remaining teeth. The percentage radiographic bone loss-to-age ratio will be 0.25-1.0.
Stage III Grade C Periodontitis

Twenty-seven adults aged 18-65 years who report smoking ≥10 cigarettes per day for more than 5 years and have stage III grade C periodontitis. Clinical criteria include clinical attachment loss ≥5 mm at ≥2 nonadjacent teeth, radiographic bone loss extending to the middle third of the root or beyond, loss of ≤4 teeth due to periodontitis, probing depths ≥6 mm, vertical bone loss ≥3 mm, and ≥20 remaining teeth. The percentage radiographic bone loss-to-age ratio will be 0.25-1.0; grade C classification will be based on smoking ≥10 cigarettes per day as a grade modifier.

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
Gingival tissue SAA1 concentration
時間枠：Baseline

SAA1 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Baseline
Gingival tissue SAA2 concentration
時間枠：Baseline

SAA2 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Baseline
Gingival tissue SAA3 concentration
時間枠：Baseline

SAA3 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Baseline
Gingival tissue SAA4 concentration
時間枠：Baseline

SAA4 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL.
Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Correlation Between Gingival Tissue SAA Protein Levels and Probing Depth
時間枠：Baseline

Correlation between gingival tissue serum amyloid A (SAA) family protein levels and probing depth, measured in millimeters (mm).
Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Plaque Score
時間枠：Baseline

Correlation between gingival tissue serum amyloid A (SAA) family protein levels and plaque score, expressed as the percentage, of examined sites with plaque.
Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Bleeding on Probing
時間枠：Baseline

Correlation between gingival tissue serum amyloid A (SAA) family protein levels and bleeding on probing, expressed as the percentage of examined sites exhibiting bleeding after probing.
Baseline
Correlation Between Gingival Tissue SAA Protein Levels and Clinical Attachment Level
時間枠：Baseline

Correlation between gingival tissue serum amyloid A (SAA) family protein levels and clinical attachment level, measured in millimeters.
Baseline

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

Burcu KARADUMAN

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 (推定)

2026年12月4日

一次修了 (推定)

2027年2月4日

研究の完了 (推定)

2027年3月4日

試験登録日

最初に提出

2026年11月4日

QC基準を満たした最初の提出物

2026年11月10日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月10日

最終確認日

2026年11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

  • SAA-GT-2026-11

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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