Volunteer study 2024 – Impact of volatile compounds on saliva secretion

 

Subject information for participation in research on saliva secretion with the aid of volatile compound. 

 

Introduction 

We would like to kindly invite you to participate in this scientific study. Before making your decision, you will be explained what the research entails and your role within it. Please read the information provided carefully and ask for an additional explanation if you have any questions. You are also welcome to discuss it with your partner, friends, or family. 

This study is conducted by the Departments of Oral Biochemistry and Periodontology, at the Academic Centre for Dentistry Amsterdam (ACTA) and has the primary objective of collecting and researching saliva and non-invasive measurements of tear quality. The Ethical Examination Committee (ETC) of ACTA has approved this study and determined that this study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO).

 

What is the aim of the study? 

Xerostomia is a condition resulting in dry mouth feeling due to change in composition of saliva and/or impaired salivary secretion. Individuals with dry mouth syndrome often suffer from difficulties with eating, speaking, taste perception and oral infections. Xerostomia has higher prevalence in polypharmacy, Sjögren disease and head and neck cancer radiation therapy patients. Treatments include use of sialagogues (remedies increasing salivary flow) for patients with partial impaired salivary secretion and salivary substitutes (mouth washes, mouth gels and oral sprays) for patients with severe salivary gland hypofunction. Unfortunately, currently available therapies are insufficient and do not resolve dry mouth feeling for a prolonged period of time, which results in an increasing need for alternative therapeutics.

Some scents, such as natural resins and volatile compounds have been shown to affect salivary flow with better outcomes than the products that are currently available on the market. The aim of this project is to investigate the impact of volatile compounds on saliva and tear secretion. 

 

How is the research executed?

During each appointment we will collect your saliva twice, resting saliva and volatile-stimulated saliva. Furthermore, we will assess your tear quality by taking photos with a specialized device. Collection of the fluids is painless. Tear quality measurements are painless and non-invasive. The research is carried out at the Departments of Periodontology and Oral Biochemistry, ACTA and analyzed in the laboratory of Department of Oral Biochemistry.  

 

What does participating mean for you? 

The researchers, or delegate students, will collect saliva samples from you. Your participation in this study is expected to take approximately 30 minutes in total. You will be asked your age, sex assigned at birth, and basic health information. In addition, you will be asked a number of questions relating to the experiment before and after the study. 

You are requested to:

• Not to eat or drink one hour prior to the experiment.

• Not to brush your teeth or use any oral care products one hour prior to the experiment.

• Not to wear perfume on the day of the experiment.

• Not to use any eyedrops during the day of the experiment. 

• Not to wear any nose piercings during the experiment.

• Not to wear makeup on the lower waterline during the experiment.

• Sit straight in a resting state during the saliva collection.

• Not to swallow the saliva during the saliva collection.

• Not to move or talk during the saliva collection.

 

Experimental procedure

Morning hours (9.30-11.00)

1. Consent form, health questionnaire and “before” questionnaire. 

2. Tear quality measurements - before. 

3. Unstimulated saliva collection. 

4. Break.

5. Odour simulated saliva collection.

6. Tear quality measurements - after.

7. “After” questionnaire. 

The study does not pose any risks to your health. 

 

Potential advantages and/or disadvantages 

You will not experience any advantages and/or disadvantages by participating in the study.  

 

If you don't want to participate or want to withdraw from the study 

You can change your decision at any time whether you want to participate in the study. Participation is therefore completely voluntary. If you decide not to participate, you don't need to do anything. If you do participate and change your mind, you can always stop without providing a reason. Please report the change in consent to the researcher immediately. The data collected up to the point of your withdrawal will be used in the research. Refusal to participate in the study has no influence whatsoever on any (dental) treatment provided by the ACTA employees. 

 

Use and storage of your personal data and saliva 

This study requires your samples and measurements to be collected and stored. This means your samples will be registered under a unique number/code. This code is further used in measurements instead of personal details, so that your anonymity is assured. All your data will remain confidential. The research data cannot be traced back to you. If you wish, we can share the results of this research with you afterwards by sending the publication to you. By signing the informed consent, you agree to the collection, storage, and analysis of the samples. You can always withdraw your informed consent.

 

No Compensation for Participating 

You will not receive any compensation for your participation in this study.

 

Do you have any questions? 

If you have any questions, please contact the research team. 

 

Contact details 

F. Bikker, biochemist. Phone: 020-5980494, email: f.bikker@acta.nl
M. Laine, dentist. Phone: 020-5980876, email: m.laine@acta.nl
W. Potocka, PhD candidate, email: w.potocka@acta.nl
Z. Assy, Postdoctoral researcher, email: z.assy@acta.nl  

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Inclusion criteria

• Healthy

• 18+

• Any sex

 

Exclusion criteria

• Prescribed medication (excluding contraception)

• Use of eyedrops

• Ocular (eye) diseases

• History of saliva pathology

• Issues with olfactory system (sense of smell)

• Current smoker

• Currently ill with flu

• Allergy to X or related compounds

• Current symptoms of rhinitis, hay fever and/or eczema

• Pregnancy and lactating

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