Comparing the Inter-dental Brush to Dental Floss
Comparison of Inter-dental Brush to Dental Floss for Reduction of Plaque and Bleeding in Areas With Intact Papilla: A Clinical Trial
調査の概要
状態
条件
詳細な説明
Purpose:
To determine if the interdental brush is just as effective at removing plaque and reducing bleeding gums between the teeth as dental floss.
Rationale:
Many people find dental floss difficult to use and thus, do not floss daily to maintain oral health and prevent gum disease. These individuals may find the interdental brush easier to use and may be motivated to use it daily for optimal oral health.
Study design:
Study subjects will use the dental floss AND the interdental brush for 12 weeks. Plaque and bleeding scores will be measured before the study begins (week 0), mid-way (week 6), and at the end of the 12 weeks. All study subjects receive a teeth cleaning prior to the first measurements and oral hygiene instructions on how to floss and use the interdental brush. Subjects will also answer 4 short questions about their product preference and ease of use.
Study subjects:
32 healthy adult volunteers with bleeding gums. To be included in the study, subjects require 8 bleeding sites, 4 areas that can accommodate the interdental brush, dexterity to dental floss, and willingness to come for 4 study visits. Exclusion criteria include smokers because this can affect the bleeding scores; individuals with braces (orthodontia) which affects plaque levels; individuals using chlorhexidine which is a prescription strength mouthwash used to treat moderate to severe gum disease; pregnant women; and those individuals requiring antibiotics prior to dental appointments. Enrolled study subjects receive a teeth cleaning (value $180), $75 for completing the study, and all study related supplies.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V6T 1Z3
- University of British Columbia Nobel Biocare Oral Health Centre
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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:
- Adults
- Minimum of 4 interproximal areas that can accommodate a minimum 0.6 mm interdental brush width
- Minimum of 8 interproximal bleeding sites upon stimulation
- Dexterity to use manual waxed dental floss
- Able to attend all 4 study visits
Exclusion Criteria:
- Require premedication with antibiotics prior to dental therapy
- Use chlorhexidine or over-the-counter mouthwash during the study
- Smoke
- Have orthodontia
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:単一グループの割り当て
- マスキング:独身
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:1
Interdental brush (IB), the intervention is a small multi-tufted brush on a wire attached to a long angled handle that is inserted in a horizontal plane between the teeth.
The IB is inserted once and removed.
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IB is a small multi-tufted brush on a wire attached to a long angled handle that is inserted in a horizontal plane between the teeth.
The IB is inserted once and removed.
|
|
プラセボコンパレーター:2
Dental floss (DF), the positive control, is waxed dental floss; nylon covered with a water soluble unflavoured wax to facilitate easier access the contact points of teeth.
DF is rubbed against the interproximal surfaces of the teeth 2-4 times on each surface.
|
DF is waxed dental floss; nylon covered with a water soluble unflavoured wax to facilitate easier access the contact points of teeth.
DF is rubbed against the interproximal surfaces of the teeth 2-4 times on each surface.
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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 |
時間枠 |
|---|---|
|
Plaque and bleeding reduction
時間枠:12 weeks
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12 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Product preference between dental floss and interdental brush
時間枠:12 weeks
|
12 weeks
|
協力者と研究者
協力者
捜査官
- 主任研究者:Pauline Imai, MSc.、University of British Columbia
- スタディディレクター:Penny Hatzimanolakis、University of British Columbia
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
本研究に関する用語
その他の研究ID番号
- H08-01078
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。