New "in Vitro" Diagnostic Test for Oral Malodour (Striptest)
New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation
This study will assess the ability of a first prototype (strip) of a new chair side test to detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines in saliva. Previous studies already showed significant correlations between oral malodor and the levels of amines in saliva. The limitation in their use as markers of oral malodour is the fact that the detection is usually carried out by complex techniques (High Performance Liquid Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass Spectrometry (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by means of a colorimetric scale without necessity of extra apparatus.
The study will be carried out with volunteers recruited at a multidisciplinary consultation for bad breath, organized at the University Hospital Leuven, Belgium.
The paper strip will be used before the routine evaluation (organoleptic score (OS), the gold standard method for the diagnosis of halitosis and the level of volatile sulphur compounds (VSC), the most used adjunct tool to diagnose halitosis).
The results of the new chair side test (strip) will be correlated with the OS and VSC measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and negative predicted values of the new chair side test will be calculated. The cut-off values for a yes/no test will be determined. The meaning of color scores will be analyzed to assign a meaningful outcome to each score with relation to odor intensity.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Leuven、ベルギー、3000
- 募集
- Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
-
副調査官：
- Jesica Dadamio, Master Bioch
-
主任研究者：
- Marc Quirynen, PhD, DDS
-
コンタクト：
- Marc Quirynen, PhD, DDS
- 電話番号：+32 16 33 24 85
- メール：marc.quirynen@uzleuven.be
-
コンタクト：
- Jesica Dadamio, Master Bioch
- 電話番号：+32 16 34 72 82
- メール：jesica.dadamio@med.kuleuven.be
-
-
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
サンプリング方法
調査対象母集団
Hundred consecutive adult subjects consulting the bad breath clinic who meet the inclusion criteria.
Number of volunteers extended to 150 in March 2012 (Amendment Research Agreement)
説明
Inclusion Criteria:
- Adults (≥18 years
- With no evidence of bad breath or bad breath of intra-oral cause (oral malodour)
- Non-smokers or smokers from whom the organoleptic evaluation can be performed (no interference from smoke odour)
Exclusion Criteria:
- Smokers from whom the organoleptic evaluation can not be performed because of interference from smoke odour
- Presence of active caries
- Presence of sinusitis or any other Oro-pharyngeal problem
- On medications which can cause malodour
- Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
- Any oral pathophysiological condition or any oral disease (e.g. oral cancer, mucositis)
- Pregnancy and nursing
- Situation considered not compatible with the study according to the investigator's opinion; the latter includes: persons under homeopathic therapy, patients who used antibiotics during the 2 months before the study, patients frequently using chewing gum, patients under corticosteroids or other serious medications.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Healthy adults
Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven
|
Colour evaluation of a strip
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 |
|---|---|---|
|
Colour evaluation of the new chair side test
時間枠：Once (during the first consult to the clinic)
|
The colour will be assessed before all the other test and after 4 minutes of contact between the strip and the saliva of the volunteer.
|
Once (during the first consult to the clinic)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Organoleptic evaluation (OS)
時間枠：Once (during the first consult to the clinic)
|
The OS will be determined by a trained and calibrated judge as described in the literature.
Briefly, patients will be asked to count from one to eleven and the judge rated the exhaled air on a 0 to 5 score ( 0 represents absence of odour, 1 is given for barely noticeable odour, 2 for slight malodor, 3 for moderate malodor, 4 for strong malodor and 5 for severe malodor).
The judge will also evaluate nasal breath in order to exclude extra-oral causes of halitosis and the odor of a sample of the tongue coating, if present.
|
Once (during the first consult to the clinic)
|
|
Total VSC reading
時間枠：Once (during the first consult to the clinic)
|
The global concentration of sulphur containing compounds will be measured using a portable breath analyzer (Halimeter®, Interscan cooperation, Chatsworth, US.
The maximum level attained (ppb) is determined by direct readings from the analog scale of the monitor.
|
Once (during the first consult to the clinic)
|
|
Specific VSC readings
時間枠：Once (during the first consult to the clinic)
|
Hydrogen sulphide, methyl mercaptan and dimethyl sulphide will be measured using a commercially available system (OralChroma™, Abilit Corporation; Osaka City, Japan).
This portable gas chromatograph is equipped with an indium oxide semiconductor gas sensor.
The concentration values (ppbv) of the three gases will be recorded.
|
Once (during the first consult to the clinic)
|
協力者と研究者
捜査官
- 主任研究者：Marc Quirynen, PhD, DDS、Universitaire Ziekenhuizen KU Leuven
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
- 20100914
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。