Double-blind, controlled, randomised, three-fold cross-over study to investigate the efficacy of two different mouthwashes in patients with intra-oral halitosis

Double-blind, controlled, randomised, three-fold cross-over study to investigate the efficacy of two different mouthwashes in patients with intra-oral halitosis - X-03164-4001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005334

Enrollment

Registered

2013-10-17

Start date

2013-10-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

R19.6

Interventions

Group 1: Sequential use of test product (Arm 1) and water (Arm 2) twice per period (evening and morning) in three periods. Randomization in two sequences (1-2-2 or 2-1-1). Arm 1: Test product MEDA0316

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Halitosis of intra-oral origin with daily periods of noticeable bad breath; otherwise healthy in the opinion of the investigator.

Exclusion criteria

Exclusion criteria: History of allergic or undesirable reactions to ingredients of study treatment; pregnancy, breast-feeding or planned pregnancy during the study. Lack of suitability for the study: Extra-oral halitosis; Oropharyngeal diseases affording treatmentund; Medical history of infectious diseases; Medical history of malignant diseases. Systemic medication related to oral dryness; Systemic antibiotic therapy within the preceding three months of the study; Current smoker; Current drug or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (morning assessment 12 hours after rinsing the mouth) based on OralChroma measurements (hydrogen sulphide) and organoleptic scoring of mouth odour strength according to Rosenberg/Greenman.	—

Secondary

Measure	Time frame
To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (morning assessment 12 hours after rinsing the mouth) based on OralChroma (Dimethyle sulphide) and Halimeter measurements of volatile sulphur compounds. To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (evening assessment 12 hours after rinsing the mouth a second time) based on OralChroma measurements, organoleptic scoring of the mouth odour strength according to Rosenberg/Greenman and Halimeter measurements.	—

Measure

Time frame

To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (morning assessment 12 hours after rinsing the mouth) based on OralChroma (Dimethyle sulphide) and Halimeter measurements of volatile sulphur compounds. To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (evening assessment 12 hours after rinsing the mouth a second time) based on OralChroma measurements, organoleptic scoring of the mouth odour strength according to Rosenberg/Greenman and Halimeter measurements.

—

Countries

Germany

Contacts

Public ContactUrsula Petzold

Meda Pharma GmbH & Co KG (a Mylan company), Scientific Affairs, Clinical Affairs Meda

ursula.petzold@mylan.com+49 6172 888 01

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026