Effect of Oral Health Ingredients on the Acquired Salivary Pellicle

NCT02188238 | Completed

• 1 other identifier: IFR01/2014
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to help us understand how saliva forms a thin film inside the surfaces of the mouth which is known as the salivary pellicle, and how this film helps to protect our teeth from decay. We know that the thickness and physical properties (viscosity and mechanical strength) of the salivary pellicle influences:-

• How we chew and sense the structure of food in our mouth.
• How we digest the food and extract nutrients from it.
• Protection against tooth decay and infection. However, studies have only recently established the different proteins within the pellicle. The effects of oral care products (e.g. toothpaste, mouthwash etc.) and ingredients they contain on pellicle formation and removal remain poorly understood. Therefore we need to understand how the formation of the salivary pellicle is controlled by ingredients it comes into contact with such as those from food and oral hygiene products (e.g. toothpaste and mouthwash). In this study, we are asking volunteers to provide samples of saliva. We will take the saliva samples back to our labs and measure how they form films under different conditions and determine the influence of ingredients from oral hygiene on the film forming properties. We will also measure the protein content of the saliva sample to see how this affects pellicle formation. Eventually, this information together with knowledge from other studies, should lead to the development of more effective oral hygiene products.

Conditions

Healthy

Keywords

saliva; protein; oral health; film; pellicle

Outcome Measures

Primary Outcomes (1)

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

  The principal output is to determine how ingredients in oral hygiene products affect the way that the protein in 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 oral hygiene products on the above measured parameters will be determined.

  Within 4 hours of saliva collection

Study Arms (1)

Saliva Sample Collection

Collection of stimulated whole mouth saliva . Whole mouth saliva is collected through stimulation by inert gum, and collecting saliva in a sterile tube.

Other: Saliva Sample Collection

Interventions

Saliva Sample Collection OTHER

Saliva samples will be collected from healthy volunteers recruited locally. Stimulated whole mouth saliva is collected through stimulation by inert gum, and collecting the saliva by gently spitting into a sterile tube.

Also known as: Stimulated Whole Mouth 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 healthy volunteers from the local community able to donate saliva samples

You may qualify if:

• Apparently Healthy
• Age: 18 - 65y
• Gender: Male or Female
• Non-smokers
• There are no restrictions regarding dietary habits

You may not qualify if:

• have known diabetes
• have any medical history of Tuberculosis or Hepatitis
• have depressed or elevated blood pressure measurements (\<90/50 or \<95/50 if symptomatic or \>160/100).
• are currently undergoing any medical investigations
• have undergone any dental or mouth surgery, or tongue piercing within the last six weeks
• take any medication which may affect saliva production
• have any ongoing or chronic dental or mouth problems that may influence saliva composition
• have jaw or chewing problems which may be exacerbated by the saliva collection procedure
• 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.
• are not prepared to remove any tongue "piercings" prior to the saliva collection procedure.
• If results of the clinical screening which indicate, or are judged by the Human Nutrition Unit's (HNU) Medical Advisor to be indicative of, a health problem which compromise the well-being of the volunteer if they participated, or which would affect the study data.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (2)

• Ash A, Burnett GR, Parker R, Ridout MJ, Rigby NM, Wilde PJ. Structural characterisation of parotid and whole mouth salivary pellicles adsorbed onto DPI and QCMD hydroxyapatite sensors. Colloids Surf B Biointerfaces. 2014 Apr 1;116:603-11. doi: 10.1016/j.colsurfb.2013.10.024. Epub 2013 Nov 12.

  PMID: 24269053 BACKGROUND

• Ash A, Ridout MJ, Parker R, Mackie AR, Burnett GR, Wilde PJ. Effect of calcium ions on in vitro pellicle formation from parotid and whole saliva. Colloids Surf B Biointerfaces. 2013 Feb 1;102:546-53. doi: 10.1016/j.colsurfb.2012.08.048. Epub 2012 Sep 7.

  PMID: 23104024 BACKGROUND

Related Links

• Link to IFR homepage
• Principal Investigator homepage

Study Officials

• Peter J Wilde, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2014
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: March 7, 2019

Record last verified: 2017-10

Locations

GB (1)