The aim of the study is to investigate the effect of an antiseptic mouthwash and tongue hygiene on the concetration of volatile sulphur compounds and morning bad breath in periodontal healthy subjects.
ID
Bron
Aandoening
Morning Bad Breath, tongue cleaning and mouthwash
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is Moring Bad Breath (MBB) and will be measured by three different methods:<br>
1. Organoleptic score:<br>
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;<br>
2. Halimeter:<br>
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);<br>
3. OralChroma assessments:<br>
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).
Achtergrond van het onderzoek
A daily fresh morning bad breath is often not feasible. Chemotherapeutic agents and tongue cleaning as an adjunct to mechanical plaque control would be valuable.
Meridol® Halitosis has shown to be an effective product on the concentration of volatile sulphur compounds and morning bad breath. Up to now the combination of the Meridol halitosis tooth & tongue gel, mouthrinse, tongue cleaner and toothbrush are lacking.
Doel van het onderzoek
The aim of the study is to investigate the effect of an antiseptic mouthwash and tongue hygiene on the concetration of volatile sulphur compounds and morning bad breath in periodontal healthy subjects.
Onderzoeksopzet
Time points:
1. Screening;
2. Visit 1: day 0;
3. Visit 2: day 1;
4. Visit 3: day 7;
5. Visit 4: day 21.
Onderzoeksproduct en/of interventie
After selection subjects are randomly divided among a test or control group. Subjects receive supervised instruction how to use their products.
1. The test group use: Meridol Halitosis tooth & tongue gel, meridol Halitosis toothbrush (twice a day), meridol Halitosis tongue cleaner (once a day), meridol Halitosis mouthrinse (twice a day);
2. The control group use: standard toothpaste (Hema brand), meridol Halitosis toothbrush (twice a day).
Clinical measurement are performed at day 0/baseline, day 1, day 7, day 21.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. > 18 years - 35 years;
2. Minimum of 20 natural teeth;
3. Non-smokers;
4. Organoleptic mean score of minimum 2.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Open active caries;
2. Absence of probing depth > 5mm probing and attachment loss > 2 mm;
3. The absence of pregnancy- breastfeeding and systemic diseases;
4. On medications which can cause malodour;
5. The absence of antibiotic in the last 2 months;
6. Participation in a clinical study within the previous 30 days;
7. Ongoing dental treatment or any other medical treatment of the oral cavity.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3100 |
| NTR-old | NTR3240 |
| CCMO | NL34505.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36247 |