Factors Controlling the Formation of Salivary Films

NCT01167504 | Completed Results

• 1 other identifier: IFR03-2010
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine how different ingredients which are found in food and other consumer products affect the ability of saliva to form surface films. Saliva forms a protective film on the surfaces inside the mouth. This film affects the way we consume and digest food and protects our teeth and other surfaces inside the mouth from disease and decay. It is not well known how this film forms, or which components in everyday life affect formation of the film, and therefore its protective properties. Samples of saliva will be collected from apparently healthy volunteers. The properties of the film (thickness, density, strength, protein composition) will be studied in the laboratory under controlled conditions. The effects of common ingredients in foods and other products such as proteins, emulsifiers, preservatives and surfactants on the formation and properties of the film will be determined. The results of this study will help us to understand how different ingredients can change the properties of saliva that may affect the way that we sense and digest food, and the ability of saliva to protect against decay and infection. This could, in the future lead to new ideas for developing:healthy foods (e.g. lower fat) that taste better, or more effective dental care products.

Conditions

Healthy

Keywords

saliva; food; sensory; oral health; film; pellicle

Outcome Measures

Primary Outcomes (1)

• Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces

  The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm\^2), density (ng/cm\^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.

  Within 4 hours of saliva collection.

Secondary Outcomes (1)

• Defined Behaviour of Salivary Film Formation

  Within 4 hours of saliva collection.

Study Arms (1)

Saliva Sample Collection

Saliva collection

Other: Saliva sample collection

Interventions

Saliva sample collection OTHER

Collection of either whole mouth saliva or parotid saliva. Whole mouth saliva is collected through stimulation by inert gum. Parotid saliva is collected by using a Lashley cup placed over the parotid duct and stimulated by a fruit sweet.

Also known as: Whole mouth saliva, Parotid saliva

Saliva Sample Collection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Apparently normal healthy volunteers from the local community able to donate saliva samples.

You may qualify if:

• Age: 18 - 65 years old
• Gender:Male or Female
• nonsmokers

You may not qualify if:

• diabetics
• medical history of Tuberculosis or Hepatitis
• depressed or elevated blood pressure measurements (\<90/50 or \<95/50 if symptomatic or \>160/100).
• take any medication which may affect saliva production
• are related to someone in the study team i.e. spouse, partner or immediate family member
• are pregnant, planning to become pregnant, or are currently breastfeeding.
• have results of the clinical screening which indicate, or are judged by the Human Nutrition Unit (HNU) Medical Advisor to be indicative of, a health problem which compromise the wellbeing of the volunteer if they participated, which would affect the study data.
• In addition, prior to each sample donation, the following conditions will be checked, and volunteers will only be allowed to donate saliva if none of the following apply:
• They have any current dental or mouth problems (bleeding gums, sores on mouth, dry mouth syndrome)
• They have had a viral illness or chest infection within last 7 days
• They are not able to produce sufficient saliva
• Volunteers will be required to avoid eating and drinking (except water) for 1 hour prior to saliva collection.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Limitations and Caveats

No adverse events were reported. The number of volunteers required gave acceptable statistics as anticipated. The study was completed on time

Results Point of Contact

• Title: Professor Peter Wilde
• Organization: Institute of Food Research

peter.wilde@ifr.ac.uk

+441603255258

Study Officials

• Peter J Wilde, PhD

  Quadram Institute Bioscience

  STUDY DIRECTOR

• Michael J Ridout

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 6, 2014
• Results First Posted: January 6, 2014

Record last verified: 2013-11

Locations

GB (1)