No registrations found.
ID
Source
Brief title
Health condition
Morning Bad Breath, drinking water and rinsing with water
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
1. 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.
Background summary
To 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.
Study objective
The purpose of the study is to assess the effect of a rinsing or drinking water on the MBB in periodontally and systemically healthy subjects.
Study design
Single visit with pre and post measurments.
Intervention
The 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.
Afdeling CPT- Parodontologie<br>
Gustav Mahlerlaan 3004
G.A. Weijden, van der
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5188307
ga.vd.weijden@acta.nl
Afdeling CPT- Parodontologie<br>
Gustav Mahlerlaan 3004
G.A. Weijden, van der
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5188307
ga.vd.weijden@acta.nl
Inclusion criteria
1. > 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 criteria
1. 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. Sjögren 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3101 |
| NTR-old | NTR3241 |
| CCMO | NL38260.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35237 |