Oil Pulling Whitening Mouthwash
2026年6月18日 更新者：Bennett Amaechi、The University of Texas Health Science Center at San Antonio
Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.
The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo).
Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo).
All mouthwashes will be used once daily last thing before bed at night.
Data will be collected on tooth shade evaluated on the anterior teeth.
調査の概要
状態
募集
詳細な説明
A total of 120 subjects who met all necessary requirements for selection as subjects will be stratified into three balanced groups (40 per group) according to age, gender, and their mean baseline tooth shade measured using the VITA Easy Shade Advance Spectrophotometer.
Males and females aged between 18 and 60 years will be enrolled.
The three groups will be randomly assigned to use one of three test mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo).
Subjects will be instructed to use their assigned mouthwash as an adjunct oral hygiene product for the 8-week treatment duration.
All subjects will be provided with the same brand of toothpaste (non-antimicrobial) and a soft-bristled toothbrush to use for their routine daily toothbrushing for the 8-week treatment duration.
All study products will be used according to their manufacturers' instructions.
However, to facilitate double blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility.
The clinical Examiner and other study team members will not discuss product-use with the subjects.
All mouthwash will be used once daily before bed at night, while toothbrushing will be performed twice daily in the morning and before bed at night.
For each test subject, assessment data will be collected at baseline, 4 weeks, and 8 weeks.
Data will be collected on tooth shade evaluated using the Lobene Stain Index, VITA Bleachedguide 3D-Master shade guide and the Vita EasyShade® Advance 4.0 Spectrophotometer on the anterior teeth.
The average summary scores will be calculated for each group on each of these measurements.
All dental examinations for data collection in all 120 subjects will be conducted by the same Clinical Examiner throughout the study.
Subjects will be examined and queried on adverse events at each study visit.
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
- 電話番号：210-567-3185
- メール：amaechi@uthscsa.edu
研究連絡先のバックアップ
- 名前：Razina Vohra
- 電話番号：210-643-9803
- メール：vohrar@uthscsa.edu
研究場所
-
-
Texas
-
San Antonio、Texas、アメリカ、78229
- 募集
- Clinical Research Facility of the Center for Oral Health and Research, UTHSA
-
コンタクト：
- Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
- 電話番号：210-567-3185
- メール：amaechi@uthscsa.edu
-
コンタクト：
- Razina Vohra
- 電話番号：210-643-9803
- メール：vohrar@uthscsa.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adult subjects aged 18-60, that are in good health.
- Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.
- Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.
- Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
- The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
- The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.
Exclusion Criteria:
- Pregnant or nursing by subject report.
- Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.
- Subjects that do not brush regularly.
- Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
- Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
- Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
- Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
- Participation in another clinical trial within the last 30 days.
- Presence of orthodontic appliances, except for removable retainers.
- Signs of advanced enamel wear, dentin exposure, or tooth fractures.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 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：陽性対照
|
positive control
|
|
プラセボコンパレーター：ネガティブコントロール
|
negative control
|
|
実験的：テスト製品
|
Test product
|
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 |
|---|---|---|
|
Measurement by the VITA Easyshade Advance 4.0
時間枠：Baseline to 8 weeks
|
A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade
|
Baseline to 8 weeks
|
|
VITA Bleachguide 3-D Master Shade Guide
時間枠：Baseline to 8 weeks
|
A single examiner will perform visual tooth shade assessment under standard lighting conditions.
Tooth shade will be scored on selected anterior teeth .
The tab marking system includes interpolated shade guide units (sgu) ranging from 1 to 29 sgu with a lower score indicating more whitening.
Subject shade rank scores will be determined for each visit by calculating the mean value across the selected anterior teeth scored.
|
Baseline to 8 weeks
|
|
Lobene Stain Index
時間枠：Baseline to 8 weeks
|
Measure of intensity and extent of extrinsic stain on the facial surfaces of 12 anterior teeth.
The teeth are divided into regions which are scored separately.
Intensity is scored from 0 (no stain) to 3 (heavy stain; dark brown to black) and extent is scored from 0 (no stain) to 3 (stain covering over two-thirds of the region).
Scores will be averaged for each subject for intensity (sum of all intensity scores/all sites graded) and extent (sum of all extent scores/all sites graded), and the composite stain score calculated by multiplying the mean stain intensity by the mean stain extent.
|
Baseline to 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Satisfaction: Subjective participant questionnaires
時間枠：8 weeks
|
Front teeth appearance: Five subjects will be selected from each study group for this purpose.
A digital imaging system, camera (Canon EOS 50D), will be used.
The camera (Canon EOS 50D) is to be attached to a standardized head positioner to allow for consistency between images.
A digital exposure will be made with include lips/cheeks retracted and anterior teeth aligned edge to edge.
Another digital exposure will also be made with the subjects smiling but covering just the area between nose and chin.
Photographs will be taken as digital images before the treatment and at the final study visit when efficacy assessments are completed.
Lighting conditions will be as described for the tooth shade assessments to ensure uniformity among subjects and consistency across time.
|
8 weeks
|
|
Satisfaction Questionnaire
時間枠：8 weeks
|
A questionnaire containing 6 scorable items with a potential score of (a) 5=Very High to (e)1=Very Low and 4 free response questions.
Total scores range from 6-30 with a higher score indicating greater satisfaction
|
8 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月1日
一次修了 (推定)
2026年8月31日
研究の完了 (推定)
2026年8月31日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年6月18日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月18日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00001211
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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