213418

Malodour Study - This Study is for E-Cigarette Users and Smokers

Study Summary

You are being asked to participate in an exploratory research study which aims to assess the impact of tobacco Products on levels of Volatile Sulphur Compound (VSCs) in the breath. VSCs is the main component of bad breath/malodour.

Subjects will must be E-cigarette smokers & Smokers. The study will involve two visits to the study site.

If you agree to participate in this study you will be required to attend a screening visit where we will assess your suitability to take part, including an oral assessment. If you are suitable to take part in the study you will have the shade of your teeth assessed, and fluid from between teeth (gingival fluid) collected, tongue scraping samples collected by a dentist. You will then be issued a standard fluoride toothpaste and standard toothbrush and instructed on use.   You will be reminded that foods and drinks which may impact the readings, e.g. onions, garlic, spicy food, alcohol, coffee will be restricted for 48 hours prior to your next visit.  An appointment will be arranged to return for visit 2.

You will return to the test centre for visit 2, where you will have a breath sample collected.  At each time point, a single breath sample will be collected using a sterile syringe and analysed with a device called an OralChroma.  A sterile mouthpiece will be inserted into your mouth and 3 breath samples taken and analysed using a device called a SIFT-MS.  Your breath will then be assessed in the laboratory using these two different instruments. You will have further breath samples collected at 5 minutes and 2 hours after cigarette or E-cigarette use. If you are a non-smoker you will have breath samples collected 5 minutes and 2 hours after the baselines sample.

Study Procedures

 

Screening Visit (Visit 1) (Approx. 1 hour):

We will ask you to refrain from eating, drinking (with the exception of water) or any oral hygiene for 2 hours prior to your screening visit.

Once you have read this form we will explain the study to you, answer your questions and if you are willing to take part, ask you to sign two copies of a consent form.  We will then ask you some questions about your health and medications.

We will also measure a Carbon Monoxide (CO) in your breath using a using a CO Monitor. You will be asked to blow into the monitor until a reading is obtained.

Part of the selection process involves an oral examination carried out by the study dentist. If you match the criteria and are accepted onto the study you will have further assessments/procedures carried out by the study dentist: Grading of teeth shade, Collection of fluid from between teeth (gingival fluid) and collection of tongue bacteria.

You will complete a questionnaire regarding cigarette and e-cigarette use. You will be provided with a standard toothpaste and toothbrush to use at home for the duration of the study and will be asked only to use the toothpaste and toothbrush provided for home use and must not use any other oral hygiene products, such as mouthwash, floss, etc  until after you have completed the study. 

You will have an appointment arranged to return to the test centre for visit 2. 

You will be asked to follow the below restriction before visit 2:

  • You should not to have anything to eat or drink (with the exception tap water until half an hour before the appointment) after 23:00 the night before your study visit.

Test Visit (Visits 2) (Approx. 2hours 30 mins)

 

At the start of the test session, you will be questioned regarding your compliance with the requirements of the study and be asked if there have been any changes in your health or medication. Your diary and study toothpaste will be collected.

You will have a baseline breath samples taken and assessed with two different scientific instruments: SIFT-MS and OralChroma. For the SIFT-MS, you will have your mouth closed for 60 seconds before sliding a sterile mouthpiece into your mouth through your closed lips. Once you are comfortable, the study personnel will draw a sample into the SIFT-MS which will measure the sample within approximately 20 seconds. This will be repeated twice more. You will be asked to breathe through your nose for the duration of this process. For the OralChroma, a single baseline breath sample will be collected. You will be asked to sit quietly and breath through your nose for 90 seconds. A sterile disposable syringe will be inserted into your mouth through closed lips and held between your lips to make a seal around the syringe, whilst you take care to avoid allowing the syringe to touch your tongue. You will then be asked to draw out the syringe plunger, push it back in and then draw out a second time to it full extent, whilst keeping the mouth closed. The study personnel will use this sample to complete the measurement.

Following this you will be accompanied outside for personal product use – smokers and e-cigarette users will use their own normal product. A further breath sample will be collected 5 minutes and 2 hours after cigarette or e-cigarette use using the same procedure as above.

For non-smokers breath samples will simply be taken 5 minutes and 2 hours after the baseline breath sample using the same procedure as above.

You will be asked to remain at the test centre for the duration of the testing procedures and will not be able to eat or drink (except for water) until the final breath sample has been taken.

  

Attendance – 2 Visits

You will be required to attend twice – one Screening Visit and one Test Visit.

 

Screening Visit (will take approx. 1 hour).– Please Choose (one) date below. Appointments will run between 9am – 4:45pm.

Wednesday 31 October 2018

Thursday 01 November 2018

Friday 02 November 2018

Monday 12 November 2018

Tuesday 13 November 2018

Test Visit -  (will take approx. 2 hours and 30 minutes) (Visit 2) Appointments will run between 8am – 10am.

 

You will be given an appointment for visit 2 if you pass the screening visit an you are enrolled onto the study.

 

Friday 02 November 2018

Wednesday 14 November 2018

Thursday 15 November 2018

Friday 16 November 2018

Wednesday 21 November 2018

Thursday 22 November 2018

Friday 23 November 2018

Wednesday 28 November 2018

Thursday 29 November 2018

Friday 30 November 2018

Inclusion Criteria

The following Inclusion Criteria will be used during subject screening and recruitment:

Males

Females (non-pregnant, non-lactating)

Aged 21-60 years inclusive. Age verification will be performed by checking government issued identification (e.g. passport or driving licence) during screening.

Good general health as judged by the Investigator or their appropriately qualified designee based on medical history

Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions.

Subjects must demonstrate the ability to understand the Informed Consent Form (ICF), be able to communicate well with the Investigator or their appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the investigator or their appropriately qualified designee.

Subjects will be willing to refrain from consuming alcohol within 48 hours prior to Screening and study visit. 

Subjects will be willing to refrain from consuming onions, garlic and spicy food, for 48 hours prior to test visit.

Good oral health with no diseases or conditions which could affect the study / have an adverse impact on the volunteer including severe gingivitis, grossly carious lesions and periodontal disease. At least 12 natural teeth, with at least 1 tooth suitable for GCF sampling (in the opinion of the dentist) per quadrant.

No scale and polish for 6 months prior to screening for all groups.

E-CIGARETTE USERS

·     E-cigarette user of a minimum of 200 puffs per day or more for more than 6 months. Subjects are to be exclusive e-cigarette users for a minimum of 6 months.

·     History of tobacco smoking and transition to e-cigarette to be documented.

SMOKERS

·      Subjects will be regular smokers of commercially manufactured filter cigarettes and including menthol cigarettes.

·      Subjects will have smoked for at least 3 consecutive years prior to Screening.

·      Subjects will typically smoke at least 10 Cigarettes per day and an exhaled breath CO level ≥ 7 ppm at Screening.  CO levels will be measured using a CO meter.

Exclusion Criteria

The following Exclusion Criteria will be used during subject recruitment:

Signs of gross or untreated caries or of significant periodontal disease, which, in the opinion of the study dentist, either would affect the scientific validity of the study or,  if the subject were to participate in the study,  would affect their wellbeing.

Orthodontic or prosthetic appliances (fixed or removable), including dental implants.

Tongue or lip piercing.

Currently participating in other dental trials.

Pregnant or breast-feeding women.

Medical condition and/or regular use of any medication which might affect the outcome of the study including:

o  Evidence or recent (within 4 weeks) history of bronchitis, tonsillitis or sinusitis.

o  Current respiratory infection, oesophageal reflux, colds, flu, sore throat.

o  Severe xerostomia, either self-reported or evidenced through oral examination.

o  Diabetics

o  Current use or use of any antibiotics within 14 days prior to screening.

o  Medications or supplements which may impact oral mouth odour within 7 days prior to the test visit, specifically Zinc containing products.

o  Current use or use of anti-inflammatory medication within 4 weeks of screening.

·     Subjects who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to Screening.

·     Subject that use “roll your own” or tobacco heating products.

·     Subjects that use chewing tobacco or snuff.

·     Subjects unable to attend for all visits.

·     Employees and immediate relatives of the tobacco industry and the clinical site.

Study Restrictions

Study Restrictions

·     Subjects will not be permitted to eat from 11pm on the evening prior to their test visit. 

·     Subjects are not permitted to brush their teeth, floss, use mouthwash or chewing gum on the morning of the screening visit.

·     Subjects are not permitted to eat and drink (with the exception of water) at the test visit. They will be permitted to sip water only before the test visit and during sampling timeframe.

·     Subjects are not permitted to brush their teeth, floss, use mouthwash or chewing gum from 11pm on the evening prior to the test visit (T2).

·     Subjects must not brush their tongue within 3 days prior to each visit.

·     Subjects must not consume breath mints, mint sweets or medicated lozenges

·     They will be requested not to smoke / use an e-cig from 11pm on the evening prior to their visit until completion of the test day (except for the use after baseline sampling).

·     Foods and drinks which may impact the readings, e.g. onions, garlic, spicy food, alcohol, will be restricted for 48 hours prior to the test visit. 

·     Subjects should not defer any necessary or emergency dental treatment but should inform study personnel if they have any carried out.

·     Subjects are not permitted to change the brand or type of cigarette or e-cigarette for the duration of the study.

·     Subjects are only permitted to use the toothbrush and toothpaste provided for the duration of the study and must not use medicated oral products, mouthwash, mouth sprays, chewing gum.

Expenses

You will be paid a £60 cheque in your name on completion of this study.

How to Apply

To take part in this study please email recruitment@albavolunteers.com.

If you do not receive a response within 5 working days it may be that you were not selected to take part on this occasion.