Surfactant Protein D Levels in GCF Before and After MINST in Periodontitis
Evaluation of Surfactant Protein D (SP-D) Levels in the GCF of Periodontitis Patients Associated With the Endpoints After Minimally Invasive Non-surgical Periodontal Therapy: A Before and After Study
This study will evaluate changes in Surfactant Protein D (SP-D) levels in gingival crevicular fluid (GCF) of patients with periodontitis before and after minimally invasive non-surgical periodontal therapy (MINST).
Participants diagnosed with stage II or III periodontitis will receive minimally invasive non-surgical periodontal treatment. GCF samples will be collected at baseline and 6 months after treatment, and SP-D levels will be measured using enzyme-linked immunosorbent assay (ELISA).
The study will also assess clinical periodontal outcomes, including full-mouth plaque score, full-mouth bleeding score, probing pocket depth, clinical attachment level, gingival recession, and patient satisfaction. Each participant will serve as their own control by comparing baseline values with 6-month post-treatment values.
調査の概要
詳細な説明
Periodontitis is a chronic multifactorial inflammatory disease characterized by progressive destruction of the supporting periodontal tissues. Conventional clinical parameters, such as probing pocket depth, bleeding on probing, and clinical attachment level, are useful for diagnosis and follow-up but may reflect tissue destruction after it has already occurred. Therefore, biomarkers that reflect the biological inflammatory status of periodontal tissues may improve monitoring of disease activity and treatment response.
Surfactant Protein D (SP-D) is an innate immune molecule involved in host defense and modulation of inflammation. It has been detected in oral fluids, including gingival crevicular fluid, and may be associated with periodontal inflammation. This study aims to evaluate whether SP-D levels in GCF change after minimally invasive non-surgical periodontal therapy in patients with periodontitis.
This is a single-group before-and-after interventional clinical study. Eligible participants with stage II or III periodontitis will be recruited from the outpatient periodontal clinics of the Faculty of Dentistry, Cairo University. At baseline, periodontal clinical parameters will be recorded, including full-mouth plaque score, full-mouth bleeding score, probing pocket depth, clinical attachment level, and gingival recession. GCF samples will be collected from selected periodontal sites using sterile paper strips and stored until biochemical analysis.
All participants will receive minimally invasive non-surgical periodontal therapy, including oral hygiene instructions, supragingival plaque control, and subgingival instrumentation using minimally invasive techniques. Treatment will be performed using fine periodontal instruments, thin ultrasonic tips, magnification when available, and local anesthesia when needed to improve patient comfort and minimize tissue trauma.
After 6 months, participants will be recalled for clinical re-evaluation and collection of post-treatment GCF samples from the same sites. SP-D levels will be measured using ELISA. The primary outcome will be the change in SP-D level from baseline to 6 months after treatment. Secondary outcomes will include changes in plaque score, bleeding score, probing pocket depth, clinical attachment level, gingival recession, and patient satisfaction.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hossam Ashraf ElMasry
- 電話番号：+201129559757
- メール：hossam.eldamarany@dentistry.cu.edu.eg
研究場所
-
-
-
Cairo、エジプト、12613
- 募集
- Faculty of Dentistry, Cairo University
-
コンタクト：
- Faculty of Dentistry, Cairo University
- 電話番号：01002159535
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male and female participants aged 18 years or older.
- Diagnosis of periodontitis, classified as stage II or stage III according to the 2018 classification system.
- Presence of at least one tooth with probing pocket depth (PPD) of 5 mm or more, clinical attachment loss (CAL), and radiographic evidence of bone loss.
- Presence of at least one intrabony defect with a radiographic intrabony component measuring 3 mm or more.
Exclusion Criteria:
- Current smokers or individuals with a history of smoking within the past year.
- Pregnant or lactating women.
- Use of systemic antibiotics or anti-inflammatory medications within the last 3 months.
- Known allergy to any materials or agents used during periodontal therapy.
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：MINST Group
Participants diagnosed with periodontitis will receive minimally invasive non-surgical periodontal therapy (MINST).
Clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and 6 months after treatment to assess changes in SP-D levels and periodontal outcomes.
|
Minimally invasive non-surgical periodontal therapy will include oral hygiene instructions, supragingival plaque control, and subgingival instrumentation using fine periodontal instruments, miniature Gracey curettes, thin ultrasonic tips, magnification when available, and local anesthesia when needed.
Debridement will be performed for periodontal pockets while minimizing trauma to the soft tissues.
他の名前：
|
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 |
|---|---|---|
|
Change in Surfactant Protein D (SP-D) Levels in Gingival Crevicular Fluid
時間枠：Baseline and 6 months after treatment
|
Change in Surfactant Protein D (SP-D) concentration in gingival crevicular fluid from baseline to 6 months after minimally invasive non-surgical periodontal therapy.
SP-D levels will be measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
|
Baseline and 6 months after treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Full-Mouth Plaque Score
時間枠：Baseline and 6 months after treatment
|
Change in full-mouth plaque score from baseline to 6 months after treatment.
Plaque score will be recorded as the percentage of sites with visible plaque.
|
Baseline and 6 months after treatment
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Change in Probing Pocket Depth
時間枠：Baseline and 6 months after treatment
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Change in probing pocket depth from baseline to 6 months after treatment.
Probing pocket depth will be measured in millimeters using a UNC-15 periodontal probe.
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Baseline and 6 months after treatment
|
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Change in Clinical Attachment Level
時間枠：Baseline and 6 months after treatment
|
Change in clinical attachment level from baseline to 6 months after treatment.
Clinical attachment level will be measured in millimeters using a UNC-15 periodontal probe.
|
Baseline and 6 months after treatment
|
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Change in Gingival Recession
時間枠：Baseline and 6 months after treatment
|
Change in gingival recession from baseline to 6 months after treatment.
Gingival recession will be measured in millimeters from the cemento-enamel junction to the gingival margin using a UNC-15 periodontal probe.
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Baseline and 6 months after treatment
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Patient Satisfaction Score
時間枠：6 months after treatment
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Patient satisfaction will be assessed at the 6-month follow-up using a standardized 5-point Likert-scale questionnaire.
Higher scores indicate greater patient satisfaction.
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6 months after treatment
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
その他の研究ID番号
- PER 7-2-1
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
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