UCL EASTMAN DENTAL INSTITUTE
PERIODONTOLOGY UNIT
Version 2.0, 10 February 2015
Principal Investigator: Dr. Francesco D’Aiuto
Study Number: P-14-60
UCL Eastman Dental Institute
Department of Periodontology
256 Gray’s Inn Road
London WC1X 8LD
Eastman Clinical Investigation Centre
020 3456 1276
Participant ID ____________
PARTICIPANT INFORMATION SHEET
Project Title: Breath Odour Panel Development
Please read this document carefully. Please ask if you do not understand or would like more
information.
1. Invitation to participate
You are being invited to participate in a research study. You are receiving this information because you have
expressed interest in participating in this study which is designed to screen individuals who may wish to be
considered for participation in future studies we will be conducting. The following information is provided so that
you can make an informed decision regarding your willingness to participate in this current screening study only.
Feel free to discuss with family and friends and ask us if there is anything that is not clear or if you would like
more information.
2. Background and purpose
People develop oral malodour (bad breath) from the breakdown of proteins by specific micro-organisms in the
mouth. The gases generated through this process are known as volatile sulphur compounds (VSC), the main
cause of bad breath. Toothpastes have the potential to change levels of these compounds. We are planning
future studies that will be aimed at evaluating whether particular toothpastes change levels of VSCs, therefore
affecting mouth odour. In order to be eligible for participation in future studies, individuals must have sufficiently
high levels of VSCs prior to enrolment. This present study is aimed at screening individuals to form a panel of
potentially suitable participants for future studies by assessing existing VSC levels.
3. Is my participation voluntary?
It is up to you to decide whether you would like to take part in this study or not. If you decide to take part, you will
be given this information sheet to keep and be asked to sign a consent form after which a copy will be given to
you. Since you are a healthy volunteer participant (not attending due to presence of a medical or dental
condition) your alternative is not to participate in this research study. Even if you sign the consent form, you are
still free to withdraw from the study at any time and you do not have to give a reason.
4. What are the requirements for taking part?
To take part in this study, you must be at least 18 years of age, in good general and oral health and must have a
minimum of 20 natural teeth (without caps or veneers). You must read and sign the Informed Consent and be
available for the 3 weeks duration of the study.
You will not be able to take part:
 If you are pregnant and/or breast feeding
 If you have had recent bronchitis, tonsillitis or sinusitis (within the last 6 weeks). If you contract a
respiratory infection, a cold, flu, sore throat or any condition which can be carried in saliva or salivary
aerosols or if you start taking antibiotics your participation in the breath odour panel build may be
suspended. If participation is suspended it must be suspended until the condition is resolved and/or a
period of 14 days has elapsed since completing your course of antibiotics"
 If you suffer from dry mouth
 If you have taken antibiotics within the previous 14 days
 If you have any mouth appliances such as braces, dentures or implants
 If you have had a scale and polish within the previous 3 weeks, or are currently undergoing dental
treatment, or have tongue or lip piercings.
5. What will happen to me if I decide to take part?
You will be asked to attend up to 4 visits in total over a duration of 3 weeks.
Page 1 of 3
Participant’s Initials: _________
Version 2.0, 10 February 2015
Principal Investigator: Dr. Francesco D’Aiuto
Study Number: P-14-60
UCL Eastman Dental Institute
Department of Periodontology
256 Gray’s Inn Road
London WC1X 8LD
Eastman Clinical Investigation Centre
020 3456 1276
Participant ID ____________
6. Are there any restrictions I will have to comply with if I take part?
 After Visit 1 you will not be allowed to use any mouthwash, mouth sprays, chew gum or use oral
deodorant products such as Clorets, Certs, or Breath Strips during your participation in this study.
 You are not allowed to have a scale and polish during the 3 weeks study.
 You will be asked to abstain from brushing your teeth for 12 hours before each of the 3 study breathassessment visits.
 You will be asked to abstain from brushing your tongue (if you normally do so) for 3 days prior to your
study visit
 You will be asked not to consume alcohol for 48 hours prior to the study visit
 You will be asked not to consume heavily spiced foods within 24 hours prior to your study visit
 You will be asked not to consume only water from 11 pm onward until after your study visit
 You will be asked not to smoke from 11 pm onward until after your study visit
7. Study Procedures
A total of up to 300 healthy volunteers will be selected for this study. Assessment for eligibility will take place at
the Screening Visit, and reassessed to confirm eligibility to continue at Visit 1, 2 and 3 with at least 2 days
minimum between each of the visits. Your mouth will be visually examined by a dental professional and you will
be asked to provide a sample of mouth air by breathing into a container which will be analysed for the levels of
VSCs. None of the techniques are invasive or painful.
Study visits and procedures are listed in sequence below:
Screening Visit (Approximately 30 minutes): You will have the opportunity to ask questions to the study staff.
If you wish to take part, you will be asked to sign two copies of the consent form. One copy will be kept by us
and the other copy, along with a copy of the information sheet, will be given to you to keep. We will ask some
questions about your medical history and examine your mouth to confirm eligibility for participation in this study.
If you are found suitable to continue in the study, three additional visits will be scheduled with a minimum of 2
days between each visit.
Visit 1 First Mouth Air Sample (Approximately 30 minutes):
You will need to refrain from toothbrushing for 12 hours before attending this visit. At this visit, staff will ask you if
there have been any changes in your health or medications since your last visit, and the dental examiner will
check the health of your mouth. Three samples of your mouth air will be collected.
Visit 2 Second Mouth Air Sample Baseline Visit (Approximately 30 minutes):
Procedures at this visit are the same as Visit 1
Visit 3 (Week 4)
Procedures at this visit are the same as Visit 1 and 2.
If you are found not eligible to continue on this study at any visit, you will be withdrawn from the study. VSC
levels must be at a pre-defined threshold in order for you to continue. In order to be eligible for future studies of
this type, the VSC levels must be at sufficient levels at each of the 3 visits above.
8. Are there any possible risks from the study procedures?
The study procedures are all non-invasive and carry no known risks.
9. What are the possible benefits in taking part?
You may be suitable to participate in future breath odour studies.
11. Will I be paid for taking part in this study?
Upon successfully completing all of the study procedures, you will receive a financial remuneration in the
amount of £80. If you withdraw from the study or if you are ineligible to continue due to low levels of VSCs in
your mouth sample, you will receive £20 per completed visit. If you do not follow the instructions given to you
exactly, you may be disqualified from continuing the study and you will receive £20 per completed visit. The
amount of compensation you receive is to cover out of pocket expenses that may be incurred whilst participating
in the study.
Page 2 of 3
Participant’s Initials: _________
Version 2.0, 10 February 2015
Principal Investigator: Dr. Francesco D’Aiuto
Study Number: P-14-60
Participant ID ____________
UCL Eastman Dental Institute
Department of Periodontology
256 Gray’s Inn Road
London WC1X 8LD
Eastman Clinical Investigation Centre
020 3456 1276
12. Will my taking part in this study be confidential?
If you consent to take part in this study, UCL Eastman Dental Institute and the Sponsor company, in accordance
with international regulatory guidelines, will store the information collected during the study. The Investigator is
responsible for safety and security of the data. Handling, processing, storage and destruction of personal data
will be in accordance with the UK Data Protection Act 1998 and UCL’s data Protection policy. The information
may also be made available within the EU to monitors, auditors (both from the research organisation and
Sponsor company), members of the Ethics Committee and staff from regulatory authorities, for the purposes of
data verification. Only UCL Eastman Dental Institute staff and the monitors will know that the information is
related to you and this information is kept separate and confidential. Some study documents may be looked at
by authorised representatives of the Joint UCLH/UCL Research & Development Unit in order to check that the
study is being carried out in accordance with Good Clinical Practice research guidelines. Professional standards
of confidentiality will be followed by the authorised representatives at all times.
The data from this study will be stored on a password protected computer in an electronic database. Only data
needed to meet the study objectives will be collected. Throughout the study, all data will be identified only by a
unique identification number. Your name is never entered into the electronic database.
13. Complaints
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do
their best to answer your questions. Contact details are provided at the end of this information sheet. If you
remain unhappy and wish to complain formally you can do this through the the Research Governance Office,
University College London (UCL). Please write to Joint UCLH/UCL Biomedical Research Unit, R&D Directorate
(Maple House), Rosenheim Wing, Ground Floor, 25 Grafton Way, London WC1E 5DB quoting reference
13/WM/0425. All communication will be dealt with in strict confidence. Every care will be taken to ensure your
well-being and safety are not compromised during the course of the study. However, special insurance
arrangements are in place in the event that something unforeseen happens and on the balance of probabilities,
harm is attributed to your participation in this study. Compensation for any injury caused by taking part in this
study will be in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI).
Broadly speaking the ABPI guidelines recommend that the Sponsor, without legal commitment, should
compensate you without you having to prove fault. This applies in cases where it is likely that such injury results
from any procedure carried out in accordance with the protocol for the study. Your right at law to claim
compensation for injury where you can prove negligence is not affected.
14. Study results
The results of this study will only be used to determine suitability of the participant for future studies.
15. Are there any reasons why my participation in this study could be ended?
You can take as much time as you need to decide upon taking part in this study. You may refuse to participate
or may discontinue participation from this study at any time without any negative effects and without needing to
give any reason. Your participation may be terminated by the Investigator if you need medication, violate the
study requirements and restrictions , experience a study related injury or for administrative reasons.
16. Ethical approval of the study
This study has been reviewed and approved by Reading Independent Research Ethics Committee (RIEC) which
is compliant with the Regulations as they relate to ethics committees and the conditions and principles of good
clinical practice.
17. Is there a contact to ask questions regarding this study?
You have the right to ask questions about this study at any time. You will be informed about any change to the
study that might concern you. Should you have questions, please contact the research site on 0203 4561276
during normal office hours.
In case of emergency you can call 07758 855364, available 24 hours.
Thank you for taking the time to read this information sheet.
A copy of this information sheet and a signed consent form will be given to you.
Page 3 of 3
Participant’s Initials: _________