Primary Objective: The aim is to evaluate, among in a group of systemically and periodontally healthy subjects, the effect of four different (commercially available) oral mouthwashes with intra-oral halitosis. In particular, what is the effect of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Intra-orale halitosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint;
- The main study parameters is the hydrogen sulphide measured by the
OralChroma.
Secondary outcome
Secondary study parameters/endpoints;
- Methyl mercaptan concentrations (ppb) measured by the OralChroma.
- The total oral sulfide concentration will be measured with the Halimeter
device.
- Breath odor intensity with organoleptic scores.
- Tongue coating and tongue colour assessed with two different indices.
- Halitosis questionnaire.
- Subjects' perception.
Background summary
Available data indicate that 10-30% of the population may have a significant
problem with intra-oral halitosis. Individuals with intra-oral halitosis
present increased concentrations of volatile sulphur compounds (VSCs), such as
hydrogen sulphide (H2S) methyl mercaptan (MM) and dimethyl sulphide (DMS) in
air from the oral cavity. The oral cavity is considered as the major source for
intra-oral halitosis. Mouthwashes containing metal salts, essential oils,
chlorhexidine, chlorine dioxide and cetylpyridinium chloride have been shown to
reduce VSCs. Some of these agents are also known to have an antibacterial
effect. Mouthwashes with a combination of different agents, claiming to reduce
intra-oral halitosis, are presently available on the market. There are,
however, few randomized controlled trials comparing the effectiveness of
different mouth rinses on intra-oral halitosis.
Study objective
Primary Objective:
The aim is to evaluate, among in a group of systemically and periodontally
healthy subjects, the effect of four different (commercially available) oral
mouthwashes with intra-oral halitosis.
In particular, what is the effect of the commercially available mouthwash
containing zinc acetate and chlorhexidine diacetate compared to
- a negative control (water),
- to a positive control mouthwash containing chlorhexidine digluconate,
cetylpyridinium and
- compared to a mouthwash containing essential oils.
Three commercially available mouthwashes are without alcohol.
Secondary Objectives:
1. To evaluate the effect a mouthwash containing zinc acetate and chlorhexidine
diacetate, compared to the different mouthwashes evaluating different tongue
coating indices.
2. To evaluate the subject*s perception of his/her own breath odor (baseline
and end and per mouthwash).
3. To evaluate the perception of the subject*s attitudes towards the different
mouthwashes used in this study.
Study design
A three week, single-centre, single-blind, four arm randomized controlled
clinical trial with four different groups.
Intervention
There will be four groups;
1. Mouthwash of CB12® (alcohol free) with active ingredients; 0.03% zinc
and chlorhexidine (0.025%).
2. Negative control group: water of Bar-le-Duc.
3. Positive control group: mouthwash Halita® (alcohol free) with the active
ingredients 0.05% cetylpyridinium chloride, 0.14% zinc and 0.05
chlorhexidine.
4. Comparison mouthwash: Listerine® Cool Mint (alcohol free) with active
ingredients essential oils.
All groups will use the same commercially available regular fluoride
dentifrice.
Study burden and risks
Neither immediate nor long-range physical risks are involved.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
- adults >= 18 of age
- classified as systemically healthy assessed by a medical questionnaire; no
systemic diseases
- - periodontally healthy classified according to the Periodical Periodontal
Screening (PPS) tool: PPS 1 or PPS 2 with not more than 2 sites with probing
pocket depts of 5mm
- have a minimum of 20 natural teeth
- having finished the necessary dental treatment(s)
- regular visit of the dentist in the past 6 months - 12 months
- intra-oral halitosis at screening (visit 1) and at baseline (visit 2 - day
0);
o hydrogen sulfide >112 ppb as measured by OralChroma and
o total volatile sulfur compound level >160 ppb as determined with a
Halimeter
o oral organoleptic score >=2
- self-reported halitosis
Exclusion criteria
- allergy or hypersensitive to any of the ingredients of the products;
o zinc acetate
o chlorhexidine diacetate
o cetylpyridinium chloride
o essential-oils
o fluoride
- smoking or quidded smoking <1 year before the screening appointment
- PPS 2 with > 2 sites with a probing pocket dept of 5mm
- PPS 3
- open carious lesions
- dental students or dental care professionals
- self-reported pregnancy and/or lactating
- systemic medication related to oral dryness
- systemic antibiotic therapy within the preceding 3 months
- smoking or stopped smoking within 1 year before the screening
- extra-oral halitosis
- night guard
- orthodontic brackets (retainer is allowed)
- removable prosthesis
- oral piercings
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81289.018.23 |