The effect of different commercially available mouthwashes with active ingredients in a group of systemically and periodontally healthy subjects with intra-oral halitosis. A three week, single-center, single-blind, four-arm randomized controlled clinical trial

The effect of different commercially available mouthwashes with active ingredients in a group of systemically and periodontally healthy subjects with intra-oral halitosis. A three week, single-center, single-blind, four-arm randomized controlled clinical trial - Clinical halitosis mouthwash study. RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56598

Enrollment

Registered

2023-10-26

Start date

2023-11-09

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-orale halitosis Bad breath and breath odor

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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 outcomes

Primary

Measure	Time frame
Main study parameter/endpoint; - The main study parameters is the hydrogen sulphide measured by the OralChroma.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)