Manual Versus Oscillating-rotating Toothbrushes After Root Coverage Procedure
Gingival Margin Stability After Mucogingival Plastic Surgery. The Effect of Manual Versus Powered Toothbrushing: a Randomized Clinical Trial
調査の概要
詳細な説明
BACKGROUND Oscillating-rotating power toothbrushes have been proven clinically efficacious. To the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. The aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.
METHODS Sixty healthy patients with at least a single Miller Class I or II gingival recession underwent surgical root coverage procedure. Soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. Full-mouth plaque score, Full-mouth Bleeding Score, Probing Pocket Depth and Recession Depth were recorded 1, 3 and 6 months after completion of surgical procedure. Longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. Temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global Wald test.
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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-
MI
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Milan、MI、イタリア、20122
- Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
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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:
- Full-Mouth Plaque Score (FMPS) ≤25%
- Full-Mouth Bleeding Score (FMBS) ≤25%
- Miller Class I and II buccal recession ≥2 mm
Exclusion Criteria:
- Relevant systemic condition or disease
- Smokers
- Teeth with prosthetic crowns or restorations in the cervical area
- Presence of pulling frenum in the keratinized tissue
- Previous mucogingival or periodontal surgery in the experimental site
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Manual Toothbrush
Patients were instructed in the Roll Brushing Technique, twice daily for 2 min.
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Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
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実験的：Oscillating-rotating toothbrush
Patients received manufacturer's instructions for use, including brushing twice daily for 2 min.
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Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH
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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 |
|---|---|---|
|
Change in Complete Root Coverage Rate
時間枠：Change in Complete Root Coverage Rate at 1 month
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 1 month
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|
Change in Complete Root Coverage Rate
時間枠：Change in Complete Root Coverage Rate at 3 months
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Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 3 months
|
|
Change in Complete Root Coverage Rate
時間枠：Change in Complete Root Coverage Rate at 6 months
|
Abscence of exposed root surface measured ad percentage
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Change in Complete Root Coverage Rate at 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Recession Depth
時間枠：Baseline, 1 month, 3 months, 6 months
|
Distance from the gingival margin to the cementum-enamel junction, measured in millimeters
|
Baseline, 1 month, 3 months, 6 months
|
|
Change in Clinical Attachment Level
時間枠：Baseline, 1 month, 3 months, 6 months
|
Distance from the cementum-enamel junction to the bottom of the periodontal Pocket, measured in millimeters
|
Baseline, 1 month, 3 months, 6 months
|
|
Change in Probing Pocket Depth
時間枠：Baseline, 1 month, 3 months, 6 months
|
Distance from the gingival margin to the bottom of the periodontal pocket, measured in millimeters
|
Baseline, 1 month, 3 months, 6 months
|
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：Giulio Rasperini、Unit of Periodontology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Foundation IRCCS Ca' Granda Policlinic
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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