Subgingival Lactobacillus Reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Diabetic Patients (LREUTERI-DM)
Effect of Adjunctive Subgingival Lactobacillus Reuteri in Non-Surgical Periodontal Therapy for Periodontitis in Patients With Diabetes: A Randomized Controlled Clinical Trial
調査の概要
詳細な説明
Periodontitis is a chronic inflammatory disease associated with dysbiotic subgingival biofilms and is strongly influenced by diabetes mellitus. Chronic hyperglycemia may impair immune function and wound healing, resulting in increased periodontal destruction and poorer treatment outcomes. Non-surgical periodontal therapy based on scaling and root planing (SRP) remains the standard treatment; however, residual periodontal pockets may persist after therapy.
Lactobacillus reuteri probiotics have demonstrated antimicrobial, anti-inflammatory, and host-modulatory properties and may enhance periodontal healing. This randomized controlled clinical trial evaluated the adjunctive effects of subgingival administration of a liquid probiotic preparation containing Lactobacillus reuteri in diabetic patients with Stage III Grade B or higher periodontitis.
Forty periodontal sites were randomly allocated to either a test group receiving SRP plus subgingival Lactobacillus reuteri probiotics or a control group receiving SRP plus saline irrigation. A second application was performed at the 1-month visit. Clinical outcomes included plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level. Glycemic control was evaluated using HbA1c levels, and microbiological analysis was performed using real-time PCR for Porphyromonas gingivalis, Tannerella forsythia, and Fusobacterium nucleatum.
Assessments were conducted at baseline, 1 month, and 3 months. The primary objective was to evaluate changes in clinical outcomes. Secondary objectives included microbiological and glycemic outcomes.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ho Chi Minh City
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Ho Chi Minh City、Ho Chi Minh City、ベトナム、700000
- Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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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:
- Age ≥18 years.
- Diagnosed with diabetes mellitus according to WHO criteria.
- Stage III Grade B periodontitis or higher according to the 2017 AAP/EFP classification.
- At least 15 remaining teeth.
- Periodontal pockets ≥5 mm with bleeding on probing.
- Clinical attachment loss ≥5 mm.
Exclusion Criteria:
- Current smokers.
- Pregnant or lactating women.
- Use of antibiotics or anti-inflammatory medications within 1 month before enrollment.
- Periodontal therapy within the previous 3 months.
- Undergoing orthodontic treatment.
- Presence of pulpal lesions or severe occlusal trauma.
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：クロスオーバー割り当て
- 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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実験的：SRP + Lactobacillus reuteri
Subgingival Lactobacillus reuteri
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Subgingival administration of liquid Lactobacillus reuteri following scaling and root planing.
The probiotic solution was applied into periodontal pockets at baseline and re-applied after 1 month.
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アクティブコンパレータ：SRP + Saline
Saline Control
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Subgingival administration of sterile saline solution following scaling and root planing.
Saline was applied into periodontal pockets at baseline and re-applied after 1 month using the same protocol as the test intervention.
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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 |
|---|---|---|
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Bleeding on Probing (BOP)
時間枠：Baseline to 3 months
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Bleeding on probing was assessed at baseline, 1 month, and 3 months after treatment.
Changes in the percentage of bleeding sites were used to evaluate periodontal inflammation.
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Baseline to 3 months
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Change in Probing Pocket Depth (PPD)
時間枠：Baseline to 3 months.
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Probing pocket depth was measured using a UNC-15 periodontal probe at baseline, 1 month, and 3 months after treatment.
The primary outcome was the change in PPD from baseline to 3 months.
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Baseline to 3 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Clinical Attachment Level (CAL)
時間枠：Baseline to 3 months.
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Clinical attachment level (CAL) was measured using a UNC-15 periodontal probe.
Changes in CAL was assessed to evaluate periodontal attachment gain following treatment.
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Baseline to 3 months.
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Changes in Glycated Hemoglobin (HbA1c)
時間枠：Baseline, 1 month, and 3 months
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HbA1c levels were assessed at baseline, 1 month, and 3 months following treatment to evaluate glycemic control.
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Baseline, 1 month, and 3 months
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Changes in Subgingival Periodontal Pathogens
時間枠：Baseline to 3 months
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Quantitative levels of Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum were assessed using microbiological analysis.
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Baseline to 3 months
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協力者と研究者
捜査官
- スタディチェア：Thu Nguyen Ngoc Yen, PhD、Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
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
その他の研究ID番号
- THS-PERIO-2026-01
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
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
糖尿病の臨床試験
Lactobacillus Reuteri Oral Solution [BioGaia]の臨床試験
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