|- candidate number||10955|
|- NTR Number||NTR3240|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jan-2012|
|- Secondary IDs||NL34505.018.11 CCMO|
|- Public Title||The effect of chemotherapeutic agents and mechanical tongue cleaning on morning bad breath.|
|- Scientific Title||The effect of chemotherapeutic agents and mechanical tongue cleaning on morning bad breath.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Morning Bad Breath, Tongue cleaning, Mouthwash|
|- Inclusion criteria||1. > 18 years - 35 years;|
2. Minimum of 20 natural teeth;
4. Organoleptic mean score of minimum 2.
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||29-nov-2011|
|- planned closingdate||1-dec-2012|
|- Target number of participants||60|
|- Interventions||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.
|- 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;
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 (OralChromaŽ) 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).
|- 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);
Subjects give their opinions about their experience of this clinical trial.
|- Timepoints||Time points:|
2. Visit 1: day 0;
3. Visit 2: day 1;
4. Visit 3: day 7;
5. Visit 4: day 21.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. G.A. Weijden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.A. Weijden, van der|
|- Sponsor/Initiator ||Academic Center Dentistry Amsterdam (ACTA)|
(Source(s) of Monetary or Material Support)
|GABA International AG|
|- Brief summary||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. |
MeridolŽ 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.
|- Main changes (audit trail)|
|- RECORD||17-jan-2012 - 7-nov-2012|