An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy
2015年2月3日 更新者：Frank Lippert
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect.
Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.
調査の概要
状態
完了
条件
詳細な説明
The evidence of milk fluoridation as a public health measure in caries prevention has been demonstrated in many clinical studies.
While these data are encouraging, the main focus now should be on the optimization of milk fluoride programs.
This protocol will concentrate on the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral caries test or model (ICT).
The ICT is an established model which features the use of gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque stagnation area.
After subject has been consented and enrolled in the study per the inclusion/exclusion criteria, two to three days following a dental cleaning, two partially demineralized specimens will be placed in the buccal flange area of the subject's mandibular partial denture.
During each of the five, three-week test periods, subjects will drink their assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk) timed minutes, wearing their mandibular partial dentures 24 hours a day during the test period.
Fluoride free toothpaste will be used two to three days before and continuously during each treatment period.
After each three-week test period, the two partially demineralized specimens will be removed from the subject's partial denture and analyzed using the surface microhardness test.
Mineral content change (as percentage of surface microhardness recovery) in these artificially induced incipient enamel lesions will be the primary outcome variable.
Each subject (n = 28) will serve as his or her own control.
研究の種類
介入
入学 (実際)
28
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。
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Oral Health Research Institute, Indiana University School of Dentistry
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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
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
- be between 18 and 80 years old and in general good health;
- willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
- wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
- be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
- be in good dental health with no active caries or periodontal disease;
- agree to comply with all subjects' responsibilities as stated in the protocol (e.g. use of study products, attendance at appointments, etc.);
- have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 ml/min; gum base stimulated whole saliva flow rate ≥ 0.8 ml/min).
- Be able to tolerate the taste and room temperature of the mixed milk product as demonstrated by drinking the milk at screening
Exclusion Criteria:
be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.
- have any medical condition that could be expected to interfere with the subject's safety during the study period;
- demonstrate an inability to comply with study procedures;
- have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. (*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study at the discretion of the Investigator.)
- be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
- be lactose intolerant or have known allergy or intolerance to milk or milk products
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
- 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：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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他の：Arm 1
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
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|
他の：Arm 2
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
|
|
他の：Arm 3
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
|
|
他の：Arm 4
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
|
|
アクティブコンパレータ：Arm 5
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design
他の名前：
Each subject will use this product during one of the five treatment periods in the crossover study design.
他の名前：
|
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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% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
時間枠：Three Weeks per each of five arms
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Three Weeks per each of five arms
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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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% Acid Resistance Score Per Each of Five Arms
時間枠：Three Weeks per each of five arms
|
% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.
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Three Weeks per each of five arms
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Enamel Fluoride Uptake Per Each of Five Arms
時間枠：Three Weeks per each of five arms
|
Enamel fluoride uptake is a measure of fluoridation of a caries lesion
|
Three Weeks per each of five arms
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2012年8月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2013年6月1日
試験登録日
最初に提出
2012年8月7日
QC基準を満たした最初の提出物
2012年8月13日
最初の投稿 (見積もり)
2012年8月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年2月23日
QC基準を満たした最後の更新が送信されました
2015年2月3日
最終確認日
2015年2月1日
詳しくは
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。
1.5 mg Sodium Fluoride in 100 ml milkの臨床試験
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