Breath freshening effects of mechanical removal of tongue biofilm

Clinical study on the breath freshening effects of mechanical removal of tongue biofilm used with oral formulations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38199132

Enrollment

Registered

2016-01-27

Start date

2015-06-02

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Halitosis Oral Health Halitosis

Interventions

This study is a randomized cross over investigation on a population of participants with above noticeable levels of oral malodour. Participants used four interventions once, with one week washout in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the study as documented on a subject informed consent form. 2. Availability at the investigational site at the specified study intervals and sampling times 3. Male and female between 18 and 70 years of age 4. Classified as healthy 5. Organoleptic score > 2 6. At least 20 own teeth with average oral hygiene (tooth brushing at least twice a day)

Exclusion criteria

Exclusion criteria: 1. Medical history of infectious diseases 2. Severe caries, gingivitis or periodontitis 3. Antibiotic medication within 1 month prior to the start of the trial or during the trial period 4. Consumption of medicated sweets containing antimicrobial agents 5. Subjects with diabetes mellitus, bronchitis, tonsillitis, sinusitis or other conditions that may contribute to oral malodour

Design outcomes

Primary

Measure	Time frame
Assessment of oral malodor by organoleptic scoring. A trained clinician sniffed the air exhaled from the mouth and nose and subjectively confirmed or deny the presence of malodour. It scored breath odor levels using the 0–5 organoleptic scale: 0 = no odor, 1 = barely noticeable, 2 = slight odor, 3 = moderate odor, 4 = strong odor, 5 = very strong odor. Measured 1hr, 3hr and 6hrs after treatment.	—

Measure

Time frame

Assessment of oral malodor by organoleptic scoring. A trained clinician sniffed the air exhaled from the mouth and nose and subjectively confirmed or deny the presence of malodour. It scored breath odor levels using the 0–5 organoleptic scale: 0 = no odor, 1 = barely noticeable, 2 = slight odor, 3 = moderate odor, 4 = strong odor, 5 = very strong odor. Measured 1hr, 3hr and 6hrs after treatment.

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Secondary

Measure	Time frame
Measurement of the bacterial density on the tongue, as one of the main causes of oral malodor is the bacterial that inhabit the tongue dorsum. Tongue scrape samples were taken using a sterile soft toothbrush and the sample plated on fastidious anaerobe agar supplemented with 7% defibrinated horse blood for isolation of anaerobes, and supplemented with vancomycin for isolation of strict gram-negative anaerobes. Colonies were counted and tongue bacterial density calculated. Measured 1hr, 3hr and 6hrs after treatment.	—

Measure

Time frame

Measurement of the bacterial density on the tongue, as one of the main causes of oral malodor is the bacterial that inhabit the tongue dorsum. Tongue scrape samples were taken using a sterile soft toothbrush and the sample plated on fastidious anaerobe agar supplemented with 7% defibrinated horse blood for isolation of anaerobes, and supplemented with vancomycin for isolation of strict gram-negative anaerobes. Colonies were counted and tongue bacterial density calculated. Measured 1hr, 3hr and 6hrs after treatment.

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Countries

United Kingdom

Contacts

Public ContactPaola Gomez-Pereira

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026