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van CCT (UK)

van CCT (UK)

The effect of rinsing or drinking water on Morning Bad Breath (MBB).

- candidate number10956
- NTR NumberNTR3241
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2012
- Secondary IDsNL38260.018.11 CCMO
- Public TitleThe effect of rinsing or drinking water on Morning Bad Breath (MBB).
- Scientific TitleThe effect of rinsing or drinking water on Morning Bad Breath.
- ACRONYMWaterslot
- hypothesisThe purpose of the study is to assess the effect of a rinsing or drinking water on the MBB in periodontally and systemically healthy subjects.
- Healt Condition(s) or Problem(s) studiedMorning Bad Breath, Drinking water, Rinsing with water
- Inclusion criteria1. > 18 years;
2. Systemic healthy, assessed by medical questionnaires;
3. Non smokers;
4. No orthodontic appliances;
5. No removable (partial) dentures;
6. Minimum 20 teeth;
7. No caries;
8. Willing and able to give a written informed consent;
9. Willing to adapted the style rule for 48 hours.
- Exclusion criteria1. Any pathological alterations of the oral mucosa/ pregnancy;
2. Participation in a clinical study within the previous 30 days;
3. Acute sinusitis or severe oral- pharyngeal infections;
4. On medications which can cause malodor;
5. Reduced salivary flow due to pathological reasons (e.g. Sj÷gren syndrome);
6. Subjects unwilling to abstain from additional oral hygiene (only tooth brushing allowed) particularly mouthrinse, chewing gums, flossing, peppermint containing product etc. and alcohol 12 hours prior the first measurement at the study site and until the completion of all measurements.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-nov-2011
- planned closingdate31-jan-2012
- Target number of participants60
- InterventionsThe study is designed as a single - blind (examiner) randomized two-arm parallel clinical trial. Pre- and post mesaurments will be carried out:
1. The control group will rinse with 15 milliliter water for 30 seconds;
2. The intervention group will drink 200 milliliter water.
- Primary outcomeThe primary outcome is Moring Bad Breath (MBB) and will be measured by three different methods:
1. Organoleptic score:
The judge is using an arbitrary 0-5 scale (Rosenberg et al. 1991a, Rosenberg et al. 1991b further modiefied by Greenman et al. 2004). The 0 represented absence of odour, 1 was given for barely noticeable odour, 2 for slight odour, 3 for moderate odour, 4 for strong odour and 5 for extremely strong odour;
2. Halimeter:
We are using a portable industrial sulphide monitor (Halimeters, Interscan Corp., Chatsworth, CA, USA). The unit is zeroed to ambient air before each measurement, using the technique established by Rosenberg et al. (1991a, b);
3. OralChroma assessments:
A portable gas chromatography (OralChroma«) using a flame photometric detector is the preferable method if precise measurements of specific gases are required. This technology is specifically designed to digitally measure molecular levels of the three major VSC (H2S, CH3SH, and dimethyl sulfide CH3SCH3).

In total there will be three different measurments to express the level of MBB.
- Secondary outcome1. Tongue coating index:
The procedure to assess coating is a modification of the method as described by Miyazaki et al. (1995) and described in detail by Mantilla Gomez et al. (2001);
2. Enquete: subjects give their opinions about their experience of this clinical trial.
- TimepointsSingle visit with pre and post measurments.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
Academical Center for Dentistry Amsterdam (ACTA)
- PublicationsN/A
- Brief summaryTo reduce the Morning Bad Breath (MBB) several websites suggest that rinsing or drinking water upon awakening is effective. Since MBB can be caused by a dry mouth. Water drinking help to stimulate the saliva production and saturate the whole mouth. Rinsing seems like the obvious first-aid measure to take (consumer websites). This home-remedy is however not supported with scientific evidence.
- Main changes (audit trail)
- RECORD17-jan-2012 - 7-nov-2012

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