Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis
Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis: a Controlled and Randomized Clinical Trial
調査の概要
詳細な説明
Scaling and root planing (SRP) is the most widely used treatment modality in periodontal therapy. However, a subset of periodontal sites does not respond adequately to this approach, and certain individuals exhibit susceptibility patterns that limit their response to initial treatment. Therefore, to overcome the limitations of SRP alone, adjunctive therapies-such as antibiotics and probiotics-may be employed.
The aim of this randomized, controlled, double-blind clinical trial is to evaluate the effects of adjunctive therapies (antibiotics and probiotics) associated with non-surgical periodontal therapy in individuals diagnosed with periodontitis stages III or IV, grades B or C. A total of sixty individuals with a clinical diagnosis of periodontitis will be treated with SRP alone or SRP combined with antibiotics or probiotics. Participants will be randomly allocated into three groups: Control (SRP), Test 1 (SRP + amoxicillin and metronidazole), and Test 2 (SRP + probiotics).
The adjunctive agents evaluated in this study will be a combination of systemic antibiotics (amoxicillin and metronidazole) and the probiotic Bifidobacterium animalis subsp. lactis HN019. Antibiotics will be administered for 14 days, three times daily, whereas probiotics will be administered for 90 days, twice daily. Adjunctive therapies will commence immediately after the first week of periodontal instrumentation.
Clinical follow-up will be conducted at baseline (pre-intervention), and at 3, 6, 9, and 12 months post-treatment. At baseline, 6 months, and 12 months, gingival crevicular fluid, subgingival biofilm, peripheral blood, and fecal samples will be collected, along with the assessment of periodontal clinical parameters. Levels of the cytokines IL-6, TNF-α, IFN-γ, IL-10, IL-1β, and IL-8 will be quantified in gingival crevicular fluid and peripheral blood samples using enzyme-linked immunosorbent assays.
Subgingival biofilm and fecal samples will be subjected to 16S ribosomal RNA gene amplification by PCR and sequenced using Illumina technology (MiSeq or MiniSeq; Illumina, San Diego, CA, USA). Sequencing data will be analyzed using reference databases of the human oral and intestinal microbiomes. Statistical analyses will be performed using an alpha level of 0.05 (p < 0.05).
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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São Paulo
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Ribeirão Preto、São Paulo、ブラジル、14040-904
- Universidade de São Paulo
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults with a diagnosis of generalized periodontitis, defined as involvement of ≥30% of teeth, classified as: Stage III or Stage IV, and Grade B or Grade C, according to the 2018 classification.
- Presence of at least one tooth with ≥1 interproximal site exhibiting: Probing depth (PD) ≥6 mm, and Clinical attachment loss (CAL) ≥5 mm.
- Presence of at least 15 teeth, excluding third molars and teeth indicated for extraction.
- Presence of at least 6 non contiguous teeth, each with ≥1 interproximal site presenting PD and CAL ≥5 mm.
Exclusion Criteria:
- Current smokers or former smokers who quit less than 5 years prior to enrollment.
- Pregnant or breastfeeding women.
- History of periodontal treatment within the previous 6 months.
- Continuous use of oral antiseptics within the last 6 months.
- Use of systemic antibiotics, corticosteroids, non steroidal anti inflammatory drugs, immunosuppressants, estrogen, estrogen receptor modulators, or medications affecting bone metabolism (e.g., alendronate, calcitonin) within the last 6 months.
- Presence of systemic conditions that may alter the host response, including: Diabetes mellitus, HIV infection, Down syndrome.
- Medical conditions requiring antibiotic prophylaxis for dental procedures (e.g., mitral valve prolapse).
- Known allergy or hypersensitivity to amoxicillin, metronidazole, penicillins, or related compounds.
- Use of probiotics within the last 6 months.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：プラセボ
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実験的：Probiotic
To compare the effects of probiotic as an adjuvant therapy
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Patients will receive probiotic lozenges as an adjuvant therapy to periodontal treatment.
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実験的：Antibiotic
To compare the effects as an adjuvant therapy
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The antibiotic group will receive amoxicilin and metronidazole, the probiotic group will receive probiotics
他の名前：
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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 |
|---|---|---|
|
Periodontal Probing Depth (PD)
時間枠：every 3 months, up to 1 year
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A full-mouth periodontal examination will be performed using a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA).
Probing depth (PD) will be measured in millimeters at six sites per tooth.
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every 3 months, up to 1 year
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Clinical Attachment Level (CAL)
時間枠：Every 3 months, up to 1 year
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Clinical attachment level (CAL) will be measured in millimeters at six sites per tooth using a North Carolina periodontal probe.
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Every 3 months, up to 1 year
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Bleeding on Probing (BOP)
時間枠：Every 3 months, up to 1 year
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Bleeding on probing will be assessed dichotomously (presence/absence) at six sites per tooth during full-mouth periodontal examination
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Every 3 months, up to 1 year
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Visible Supragingival Biofilm
時間枠：Every 3 months, up to 1 year
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Presence or absence of visible supragingival biofilm will be assessed on four tooth surfaces during full-mouth periodontal examination.
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Every 3 months, up to 1 year
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Distance from Cementoenamel Junction to Gingival Margin
時間枠：Every 3 months, up to 1 year
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The distance from the cementoenamel junction to the gingival margin will be measured in millimeters at six sites per tooth.
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Every 3 months, up to 1 year
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Suppuration
時間枠：Every 3 months, up to 1 year
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Suppuration will be assessed dichotomously (presence/absence) at six sites per tooth during periodontal examination.
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Every 3 months, up to 1 year
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Michel Reis Messora, PhD、University of Sao Paulo
出版物と役立つリンク
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
追加の関連 MeSH 用語
その他の研究ID番号
- 75898223.7.0000.5419
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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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