Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Laboratory and Clinical Evaluation of an Innovative Mouthwash in School-Aged Children With Fixed Orthodontic Appliances
Fixed metal orthodontic appliances create additional plaque-retentive areas around brackets, archwires and ligatures, making mechanical plaque control more difficult in children and adolescents. Increased plaque accumulation may contribute to gingival inflammation, bleeding, halitosis and early enamel changes. Therefore, adjunctive preventive agents, including mouthwashes, may be clinically useful as part of a comprehensive oral hygiene program during fixed orthodontic treatment.
The aim of the study is to evaluate the clinical effectiveness and tolerability of a test mouthwash in children and adolescents with fixed orthodontic appliances by monitoring plaque accumulation, gingival inflammation, gingival bleeding and halitosis.
調査の概要
状態
条件
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：Tanya Zalamova
- 電話番号：00359878752567
- メール：Tanya.Zalamova@mu-plovdiv.bg
研究連絡先のバックアップ
- 名前：Ani Belcheva, PhD
- メール：abeltcheva@gmail.com
研究場所
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Plovdiv、ブルガリア、4000
- Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv
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コンタクト：
- Tanya Zalamova
- 電話番号：00359878752567
- メール：Tanya.Zalamova@mu-plovdiv.bg
-
主任研究者：
- Zalamova
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Participants aged 12 to 17 years.
- Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment.
- Generalized plaque-induced gingivitis.
- Full Mouth Bleeding Score greater than 30%.
- Gingival Index greater than 0.95 according to Loe and Silness.
- Written informed consent obtained from a parent or legal guardian.
- Participant willingness to comply with the study protocol.
Exclusion Criteria:
- Refusal to participate or withdrawal of informed consent.
- Non-compliance with the intervention regimen or inability to attend follow-up visits.
- Development of an adverse reaction or condition requiring discontinuation.
- Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes.
- Presence of concomitant systemic diseases.
- Current systemic medication intake that could influence oral health or inflammatory status.
- Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents.
- Known allergy or hypersensitivity to any component of the tested mouthwash formulations.
- Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：Test Mouthwash
Participants rinsed with 15 ml of the prototype chlorhexidine-free pediatric mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml prototype chlorhexidine-free pediatric mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
他の名前：
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アクティブコンパレータ：Chlorhexidine Mouthwash
Participants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml chlorhexidine-containing mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
他の名前：
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プラセボコンパレーター：Placebo Mouthwash Group
Participants rinsed with 15 ml of the placebo mouthwash for 30-60 seconds twice daily for 21 days as an adjunct to standard oral hygiene.
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Participants rinsed with a 15 ml placebo mouthwash for 30-60 s twice daily for 21 days as an adjunct to standard oral hygiene.
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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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Orthodontic Plaque Index (OPI)
時間枠：Baseline, day 7, day 21, and 3 months
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The Orthodontic Plaque Index focuses on the areas around the bracket, which represents an additional plaque-retentive factor. The dentition is divided into sextants and plaque accumulation is scored from 0 to 4. The mesial, distal, incisal and cervical areas around each bracket are evaluated. The highest score among all sextants defines the oral hygiene level and identifies the need for preventive measures. Registry field data Code 0 No plaque accumulation is detected. Code 1 Plaque accumulation is detected on one tooth surface around the bracket base. Code 2 Plaque accumulation is detected on two tooth surfaces around the bracket base. Code 3 Plaque accumulation is detected on three tooth surfaces around the bracket base; increased risk of caries and gingivitis is assumed. Code 4 Plaque accumulation is detected on all tooth surfaces around the bracket base and/or gingival inflammation is present. |
Baseline, day 7, day 21, and 3 months
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Gingival Index (Loe & Silness)
時間枠：Baseline, day 7, day 21, and 3 months
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The index evaluates color, contour and bleeding of the gingival tissues. A World Health Organization (WHO) 621 periodontal probe is used to examine the gingival sulcus, and bleeding is recorded within 10 seconds. Code 0 Normal gingiva. Code 1 Mild inflammation: slight color change and slight edema, without bleeding on probing. Code 2 Moderate inflammation: redness, edema and glazing, with bleeding on probing. Code 3 Severe inflammation: marked redness and edema, ulceration and tendency to spontaneous bleeding. |
Baseline, day 7, day 21, and 3 months
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Full Mouth Bleeding Score (FMBS)
時間枠：Baseline, day 7, day 21, and 3 months
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FMBS assesses provoked bleeding from the gingival sulcus using a WHO 621 periodontal probe.
Bleeding is recorded within 10 seconds and marked as present (+) or absent (-).
The index is calculated as the percentage of gingival sites with provoked bleeding from all examined sites for each child.
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Baseline, day 7, day 21, and 3 months
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Full Mouth Plaque Score (FMPS)
時間枠：Baseline, day 7, day 21, and 3 months
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Dental plaque accumulation was assessed using the Full Mouth Plaque Score.
The presence of visible plaque was recorded on tooth surfaces, and the result was expressed as the percentage of plaque-positive sites.
Lower percentages indicate improved plaque control.
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Baseline, day 7, day 21, and 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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Halitosis Assessment
時間枠：Baseline, day 7, day 21, and 3 months
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Halitosis was assessed by gas chromatography using OralChroma™.
Volatile sulfur compounds were measured, including hydrogen sulfide, methyl mercaptan and dimethyl sulfide.
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Baseline, day 7, day 21, and 3 months
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協力者と研究者
捜査官
- 主任研究者：Tanya Zalamova、Plovdiv Medical University
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
追加の関連 MeSH 用語
その他の研究ID番号
- 17/2024
- 02/2024 (その他の識別子：Medical University Plovdiv)
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