Breath freshening effects of mechanical removal of tongue biofilm
| ISRCTN | ISRCTN38199132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38199132 |
| Secondary identifying numbers | Philips ICBE number: ICBE-2-1652. East of England Cambridge Central NRES committee (REC reference: 14/EE/0206) |
- Submission date
- 14/12/2015
- Registration date
- 27/01/2016
- Last edited
- 15/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Bad breath (halitosis) is a common problem that can affect anyone at any age. Although not life threatening, it can cause distress and affect how they interact with other people. Bad breath might be caused by microbes on the surface of the tongue. Cleaning the tongue with a toothbrush has shown to reduce bad breath, but the effects are short lived and doesn’t work for the whole day. The use of a newly designed tongue brush head made from soft silicone microbristles might be more successful at reducing bad breath and therefore relieve the stress and discomfort that this condition can cause. It is used on a power toothbrush handle, as sonic motions clean the tongue better than manual movements. It is also used with a tongue spray that contains mint fresh flavors and other compounds that trap smell gases. This study is looking at whether this new toothbrush combined with an antibacterial tongue spray (BreathRX tongue spray) results in long lasting fresh breath.
Who can participate?
Adults aged between 18-70 with bad breath.
What does the study involve?
Participants are randomly allocated to one of four groups. The first group is given the tongue brush to use along with the BreathRX spray, for one morning. Group 2 are given the tongue brush to use and a water spray. Participants in the third group are given BreathRX alone to use. Participants in group 4 are only given water. Bad breath is then measured for every participants in the study, for up to 6 hours. Bacteria from a tongue scrape sample is also counted to see if the root cause of bad breath –bacteria living in the dorsum (surface) of the tongue- are reduced. All participants are given all 4 treatments in turn, with a week passing before they are given the next one (this is called a washout period).
What are the possible benefits and risks of participating?
The only direct benefit for participants in this study is a possible reduction in their halitosis. However,
the information and knowledge that is gained through this study will help benefit people in the future by selecting the best treatments. No major side effects of the treatments are expected to occur. Some participant may experience gagging or a slight burning sensation of the tongue after using the BreathRX tongue spray, but these symptoms will only last for a few seconds.
Where is the study run from?
University of the West of England (UK)
When is the study starting and how long is it expected to run for?
June 2015 to July 2015
Who is funding the study?
Philips Electronics UK
Who is the main contact?
1. Dr Saliha Saad (scientific)
2. Dr Paola Gomez-Pereira (public)
Contact information
Scientific
University of the West of England
Coldharbour Lane
Frenchay Campus
Bristol
BS16 1QY
United Kingdom
 ORCID ID |
0000-0002-4436-7053 |
|---|
Public
101 Cambridge Science Park
Milton Road
Cambridge
CB4 0FY
United Kingdom
Study information
| Study design | Randomized cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical study on the breath freshening effects of mechanical removal of tongue biofilm used with oral formulations |
| Study hypothesis | The primary hypothesis of this clinical investigation is that the combination of the tongue brush with the antibacterial BreathRX tongue spray delivers a long lasting fresh breath. We hypothesized that the tongue brush with BreathRX will show a significantly higher reduction in organoleptic score at 6hrs than all other alternative treatments (tongue brush with sterile water, BreathRX alone, sterile water alone (control)). These hypotheses will be accepted or rejected based on the outcome of this clinical investigation. |
| Ethics approval(s) | Hampstead NRES Committee London, 08/04/2015, ref: 15/LO/0659 |
| Condition | Halitosis |
| Intervention | 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 between them. After each intervention, endpoints were measured 1hr, 3hr and 6hrs after treatment. The interventions are: 1. Tongue brush with BreathRx antibacterial spray. 2. Tongue brush with water spray 3. BreathRx alone 4. Water The tongue brush consists of 200 microbristles mounted on an EasyClean Philips Sonicare power toothbrush handle. It was used for a total of 60 sec, in 20 sec intervals. At each interval, 3 sprays of either BRx or water (approximately 0.6 mL) were placed on the tongue, followed by brushing. BRx or water alone treatments consisted of the same number and repetitions and volumes of the given spray alone. The third arm consisted of using Breath RX on its one on the form of a spray (without the tongue brush). Participants were advised to use one spray of Breath RX and hold it for 20 seconds on the tongue before spitting it out. This was repeated a second and third time so that 3 sprays of breath RX were used in total. The fourth arm consisted of using sterile water on its one on the form of a spray (without the tongue brush). Participants were advised to use one spray of water and hold it for 20 seconds on the tongue before spitting it out. This was repeated a second and third time so that 3 sprays of water were used in total. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 02/06/2015 |
| Overall study end date | 11/07/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 02/06/2015 |
| Recruitment end date | 13/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Frenchay Campus
Bristol
BS16 1QY
United Kingdom
Sponsor information
Industry
Philips Centre
Guildford Business Park
Guildford
GU2 8XH
United Kingdom
"ROR" |
https://ror.org/04ktqp584 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results of this clinical investigation will be published in a peer reviewed journal, and in conferences. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/02/2016 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
15/02/2016: Publication reference added.
