Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
96 participants
INTERVENTIONAL
2013-03-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fluoride rinse
A fluoride rinse with alcohol was chosen because its similarity in color and aroma to the active rinses. This anti-cavity rinse does not contain any active components and therefore it is not expected to have any anti-malodour activity.
Fluoride rinse
rinse with 15 ml for 1 minute
Halita
Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003)
Halita
rinsing with 15 ml for 1 minute
Meridol Halitosis
This study aims to confirm the effect of meridol®Halitosis(AmF/SnF2 and zinc) already observed in volunteers with morning bad breath (physiological)(Wigger-Alberti et al, 2010; Wilhelm et al, 2010)in patients with oral malodor (pathological).
Meridol Halitosis
rinsing with 15 ml for 1 minute
Water
To distinguish the masking effect caused by the formulations and the one caused by the rinsing itself.Only for short term evaluation (15') to not to compromise compliance of patients.
Water
rinsing with 15ml for 1 minute
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluoride rinse
rinse with 15 ml for 1 minute
Halita
rinsing with 15 ml for 1 minute
Meridol Halitosis
rinsing with 15 ml for 1 minute
Water
rinsing with 15ml for 1 minute
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
* Organoleptic score of breath ≥ 2
* VSC readings (sum of H2S and CH3SH by OralChroma) ≥ 120 ppb\*
* Intra-oral cause of bad breath
* Non-smokers
* Willing to participate and able to give written informed consent
Exclusion Criteria
* Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study
* Any pathological change of the oral mucosa
* Use of prohibited treatments / therapies and/or abuse of drugs, alcohol, etc
* Pregnancy or breastfeeding
* Active caries
* Acute sinusitis
* Severe oro-pharyngeal infections
* On medications which can cause malodour
* Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
* Situation considered not compatible with the study according to the investigator's opinion; the latter includes: patients eating very spicy food, persons under homeopathic therapy, patients who used antibiotics during the 2 months before the study, patients frequently using chewing gum, patients under corticosteroids or other serious medications.
* Patients unwilling to abstain from additional oral hygiene (only toothbrushing allowed) particularly mouthrinse, chewing gums, breath strips, etc
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gaba International AG
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marc Quirynen
PhD DDS
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Quirynen, PhD, DDS
Role: PRINCIPAL_INVESTIGATOR
Universitarie Ziekenhuis Leuven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Periodontology, KULeuven
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jesica Dadamio, Master Bioch
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Quirynen M, Dadamio J, Van den Velde S, De Smit M, Dekeyser C, Van Tornout M, Vandekerckhove B. Characteristics of 2000 patients who visited a halitosis clinic. J Clin Periodontol. 2009 Nov;36(11):970-5. doi: 10.1111/j.1600-051X.2009.01478.x. Epub 2009 Oct 6.
Wilhelm D, Gysen K, Himmelmann A, Krause C, Wilhelm KP. Short-term effect of a new mouthrinse formulation on oral malodour after single use in vivo: a comparative, randomized, single-blind, parallel-group clinical study. J Breath Res. 2010 Sep;4(3):036002. doi: 10.1088/1752-7155/4/3/036002. Epub 2010 Aug 17.
Wigger-Alberti W, Gysen K, Axmann EM, Wilhelm KP. Efficacy of a new mouthrinse formulation on the reduction of oral malodour in vivo. A randomized, double-blind, placebo-controlled, 3 week clinical study. J Breath Res. 2010 Mar;4(1):017102. doi: 10.1088/1752-7155/4/1/017102. Epub 2009 Dec 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GASAS-1205X
Identifier Type: -
Identifier Source: org_study_id