The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases
The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial
A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β).
The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.
調査の概要
状態
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：Hatice Yemenoglu
- 電話番号：+905052977517
- メール：htcymnglu@hotmail.com
研究場所
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Rize、トルコ（Türkiye）、53020
- 募集
- Recep Tayyip Erdogan University
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コンタクト：
- Hatice Yemenoglu
- 電話番号：+904642220000
- メール：htcymnglu@hotmail.com
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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:
- Study groups will be formed according to the 2017 Periodontal Disease Classification. Accordingly:
- Periodontally healthy; absence of bleeding on probing, erythema, edema, patient symptoms, attachment, and bone loss
- Gingivitis; patients with an average gingival index ≥0.5 according to Löe and Silness
- Stage I-II periodontitis; patients with CAL 1-2 or 3-4 mm and a maximum PPD ≤5 mm, showing radiographic horizontal bone loss up to the coronal third of the root (15%-33%), but without tooth loss due to periodontitis
- Stage III-IV periodontitis; Stage 3 and 4 patients with ≥15 teeth in their mouth, with CAL ≥5 and PPD ≥6 in at least 6 areas, and radiographic bone loss extending to the middle or apical third of the root.
Exclusion Criteria:
- Individuals who have undergone periodontal treatment in the last 6 months, have systemic diseases (such as diabetes, parathyroid and thyroid-related endocrine diseases) that may affect periodontal status, patients with chronic liver disease, hypoparathyroidism and renal failure, those who have been using medications that may affect periodontal response (aspirin, non-steroidal anti-inflammatory drugs or steroids) for a long time, those who are using additional vitamin D or calcium supplements in the pre-study phase, those who are pregnant or breastfeeding, and those with hypercalcemia and malabsorption syndrome will not be included in the study.
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：診断
- 割り当て：ランダム化
- 介入モデル：階乗代入
- 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 |
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実験的：Group 1: Stage I-II periodontitis group with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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実験的：Group 2: Stage I-II periodontitis group with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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実験的：Group 3: Stage III-IV periodontitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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実験的：Group 4: Stage III-IV periodontitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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実験的：Group 5: Chronic gingivitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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実験的：Group 6: Chronic gingivitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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実験的：Group 7: Periodontally healthy group with sufficient vitamin D levels
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Participants will receive oral hygiene education
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実験的：Group 8: Periodontally healthy group with vitamin D deficiency
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Participants will receive oral hygiene education
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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 |
時間枠 |
|---|---|
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Probing pocket depth (PPD)
時間枠：These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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Clinical attachment level (CAL)
時間枠：These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Collection of gingival crevicular fluid and serum samples
時間枠：These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
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These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
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