Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Participants also evaluated their experience with each mouthwash using a questionnaire.
調査の概要
詳細な説明
This single-center, randomized controlled crossover study compared mouthwashes containing 0.02% hypochlorous acid (HOCl) and 0.2% chlorhexidine (CHX) using a four-day plaque regrowth model. Thirty participants were enrolled, and 26 completed both treatment periods.
Each mouthwash was used twice daily, with 10 mL rinsed for one minute, during a four-day period. The treatment periods were separated by a 14-day washout period. Professional prophylaxis was performed at the beginning of each treatment period. Participants refrained from toothbrushing and interdental cleaning during the treatment periods.
Clinical assessments included the Modified Plaque Index, bleeding on probing, and the Modified Stain Index. Supragingival plaque samples were collected at the end of each treatment period for microbiological analysis, including bacterial colony counts and identification by MALDI-TOF mass spectrometry. Participants completed a questionnaire evaluating their experience with each mouthwash and indicated their final preference.
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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Ankara、トルコ（Türkiye）、06000
- Baskent University Faculty of Dentistry
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Systemically healthy.
- Aged 18-65 years.
- Having at least 22 natural teeth.
- Nonsmoker.
- Willing to abstain from alcohol throughout the study.
Exclusion Criteria:
- Presence of periodontitis or gingivitis.
- Pregnancy or breastfeeding.
- Use of medications that may affect periodontal status.
- Antibiotic or anti-inflammatory medication use within the previous six months.
- Use of antimicrobial mouth rinses, gels, or chewing gums within the previous three months.
- Known allergy to any component of the study mouth rinses.
- Presence of tongue conditions, such as geographic tongue or hairy tongue.
- Periodontal probing depths of 4 mm or greater.
- Gingival recession of 2 mm or greater.
- Use of fixed or removable dental prostheses, including single crowns, or orthodontic appliances.
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：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HOCl followed by CHX
Participants used 0.02% hypochlorous acid mouthwash for four days, followed by a 14-day washout period, and then 0.2% chlorhexidine gluconate mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute. |
Rinse with 10 mL for one minute, twice daily for four days. Rinse with 10 mL for one minute, twice daily for four days. |
|
実験的：CHX followed by HOCl
Participants used 0.2% chlorhexidine gluconate mouthwash for four days, followed by a 14-day washout period, and then 0.02% hypochlorous acid mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute. |
Rinse with 10 mL for one minute, twice daily for four days. Rinse with 10 mL for one minute, twice daily for four days. |
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 |
|---|---|---|
|
Modified Plaque Index
時間枠：At the end of each four-day treatment period.
|
Dental plaque was assessed using the modified Silness and Löe Plaque Index at six sites per tooth. Each site was scored from 0 (no plaque) to 3 (abundant plaque). Mean scores were calculated for the full mouth and 12 anatomical regions and compared between the HOCl and CHX treatment periods. Mean scores range from 0 to 3; higher scores indicate greater plaque accumulation. |
At the end of each four-day treatment period.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total culturable bacterial count in supragingival plaque
時間枠：At the end of each four-day treatment period.
|
Total culturable bacterial counts were measured in supragingival plaque samples collected from molar teeth and expressed as colony-forming units per milliliter (CFU/mL). Counts were compared between the HOCl and CHX treatment periods. |
At the end of each four-day treatment period.
|
|
Bleeding on Probing (BOP)
時間枠：At the end of each four-day treatment period.
|
Bleeding was assessed at six sites per tooth using a periodontal probe. Sites showing bleeding within 30 seconds after probing were recorded as positive. BOP was calculated as the number of bleeding sites divided by the total number of examined sites, multiplied by 100. Full-mouth and regional percentages were calculated. Scores range from 0% to 100%; higher values indicate more gingival bleeding. |
At the end of each four-day treatment period.
|
|
Modified Stain Index (MSI)
時間枠：At the end of each four-day treatment period.
|
Extrinsic tooth staining was assessed in four regions on each buccal and lingual/palatal tooth surface. Intensity was scored from 0 to 3. Area was scored from 1 to 3 only when intensity was 2 or 3, using the region-specific criteria of Macpherson et al. (2000). For intensity scores of 1, the intensity × area value was defined as 1. The participant-level MSI was calculated by averaging these values across examined regions, with a range of 0-9. Higher scores indicate greater staining. |
At the end of each four-day treatment period.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant-reported experience with mouthwashes
時間枠：At the end of each four-day treatment period.
|
At the end of each treatment period, participants completed a five-item questionnaire assessing mouthwash taste, effects on taste perception, perceived tooth cleanliness, perceived tooth discoloration, and nausea associated with mouthwash use. Each item was rated as 1 (poor), 2 (moderate), or 3 (good). Higher scores indicate a more favorable participant rating. Each item was evaluated separately. |
At the end of each four-day treatment period.
|
|
Final mouthwash preference
時間枠：After completion of both four-day treatment periods and the intervening 14-day washout period.
|
After completing both treatment periods, participants indicated which of the two mouthwashes they preferred. The number of participants preferring each mouthwash was recorded. |
After completion of both four-day treatment periods and the intervening 14-day washout period.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mehtap Bilgin Cetin, Associate Professor、Baskent University
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
- MR1234
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
A decision regarding sharing individual participant data has not yet been made.
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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